Data set compilation of Alerts and Recalls...Data set compilation of Alerts and Recalls Supplementary material of the JRC Technical Report "Exploiting globally available safety information

Data set compilation

of

Alerts and Recalls

Supplementary material

of the

JRC Technical Report

"Exploiting globally available safety information on medical

devices to enhance EU market surveillance/vigilance"

Nr AUT M DATE MFR DVC BACKGROUND/REASON ACTIONS/INSTRUCTIONS

DISTRIBUTION LIST

1 AUS Alert 03/05/16 Smith & Nephew Pty Ltd

Birmingham Hip Product Range

Smith & Nephew is issuing an update to a Medical Device Hazard Alert issued in 2015 to provide surgeons and hospitals with updated information on the BIRMINGHAM HIP RESURFACING (‘BHR’) product range and the BIRMINGHAM HIP MODULAR HEAD (BHMH) System. This update contains a current summary of the information concerning the revision rates of various products in the BHR and BHMH Systems (including the Monoblock version of the BHMH System).

Hazard Alert - The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances.

2 AUS Recall 03/05/16 Siemens

Healthcare Pty Ltd

ADVIA Centaur XPT Systems. An in vitro diagnostic medical

device (IVD)

Siemens Healthcare Diagnostics has identified an issue with the ADVIA Centaur XPT default setting for the Daily Maintenance Task (or Daily Cleaning Procedure) frequency. Instruments may have the Daily Maintenance Task frequency set to “As needed” instead of “Daily”. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results.

Recall for product correction - Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.

3 AUS Recall 03/05/16 Ecomed Pty Ltd

Xhibit Central Station (patient monitoring system)

The manufacturer, Spacelabs, has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, causing a bedside monitor Body Surface Area (BSA) calculation to be in error. No one has been injured due to this error. In order for the error to occur, the height and weight values must have been entered at the Xhibit Central Station, the Cardiac Output cable must be attached for use, and the Cardiac Output function on the bedside monitor must be initiated. The BSA value is determined by the monitor from height and weight of the patient and is used in subsequent hemodynamic calculations such as Cardiac Index.

Recall for product correction - Ecomed is providing users with work around instructions to follow as an interim measure. Affected customers will be provided with a software upgrade as a permanent correction.

The bedside monitor also contains a “drug calculator” for computation of drug dose conversions by weight or other units of measure. In situations where the failure mode has occurred, this initial value will not be accurate due to the height and weight transposition.


Healthcare Pty Ltd

ADVIA Chemistry XPT System with software versions 1.0.3

and 1.1. An in vitro diagnostic medical device (IVD)

Siemens has identified multiple software issues that may affect the day-to-day behaviour and/or workflow of the system. 1. All levels of QC run when only 1 is selected in Start/Restart window 2. Changing the display name of an assay deselects that method in its associated QC panel, therefore QC for the renamed assay will not run as part of the panel. 3. A Workstation Services restart screen may appear under multiple scenarios, causing the user interface to be temporarily inaccessible. The user will be prompted to login once the services restart. a.Workstation services may restart if a user defined filter is created in the Test Results Overview screen that includes the 31st day of the month, but is run in a month that does not have 31 days. b.Workstation services may also restart when all items are removed from the Watchlist. 4. The Chemistry XPT software does not update assay utilisation counters for ISE tests when patient samples and QC samples are run in version v1.1.

Recall for product correction - Siemens is providing users with work around instructions to follow as an interim measure. A software upgrade will be installed as a permanent correction. Users are advised to review the issues with the Medical Director.

6 AUS Recall 05/05/16

Draeger Medical Australia Pty Ltd

D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent

and Bottles) Manufacturer: Draeger

Medical Australia Pty Ltd

Baxter has been advised by Dräger of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. Dräger has identified two potential root causes for the reported issues of unwanted release of evaporating agent after filling:

Recall for product correction - Baxter is advising users to adhere to the product IFU when handling the device. Recently updated Material Safety Data Sheets (MSDS) of Desflurane manufacturers recommend the wearing of safety glasses when handling these substances.

A. Non observance of the correct filling procedure, especially with regards to the 2 to 3 seconds pause before bottle removal after filling; and B. High friction of the drug bottle valve inside the vaporiser opening may delay closing of the bottle valve after filling The release of unintended evaporating agent may lead to spraying of aerosol into face and eyes of the operator. Eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended.


Lima Orthopaedics Australia

Pty Ltd

SMR Glenosphere Impactor Manufacturer: Lima

Orthopaedics Australia Pty Ltd

Lima Orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors. The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector. If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. Although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient.

Recall for product correction - Customers are advised to inspect stocks and quarantine the affected units prior to their return.


Philips Electronics Australia

Ltd

MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)

During recent evaluations of the Philips MobileDiagnost wDR 2, Philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions. 1. The system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “Normal”), even though the patient type “Newborn” was selected and is displayed in the generator control area of the Eleva User Interface.

Recall for product correction - Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

2. Under certain conditions, the detector might not be ready for examination. Released x-ray might lead to an image with artefacts and a retake is required. While the attachment process is running, the detector might be too short in front of the IR (Infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.



Ltd

Ingenuity Core128 CT System

During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. The nonconforming fasteners may have been used to manufacture Ingenuity CT systems. The fasteners are used to secure sub-components of the adjustment cradle within the system gantry. Analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. However given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). Since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime. Repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. There have been no reports of injuries.

Recall for product correction - Philips is advising users that a field service technician will replace the affected screws on all affected systems.

10 HC Recall 02/05/16

BECKMAN COULTER

INDIA PRIVATE LIMITED 50-B, II PHASE, PEENYA

INDUSTRIA

DURACLONE B27

Lot or serial number: 210116

Beckman Coulter has identified that the reagent lot identified above was inadvertently released to market despite not meeting its full product specification. The HLA-B27 Median Fluorescence Intensity (MDFI) of this lot is higher than lots meeting the product specification, which may lead to: (1) an indicated result in the indeterminate zone when the true result is

L

BANGALORE

INDIA

in the negative range, or (2) an indicated result in the positive range when the true result is in the indeterminate zone. The issue was discovered on 16, March 21 during periodic review of our batch records. There has been no report of death or injury related to this defect.

11 HC Recall 02/05/16

Beckman Coulter,

Inc. 250 S.

Kraemer Blvd. Brea

92821 California UNITED STATES

GASTROCCULT 40T Lot or serial number: More than 10 numbers, contact

manufacturer.

Beckman Coulter has confirmed an issue where the pH test area for the Gastroccult kit may display an unexpected color for a sample at a pH 7 reading when compared to the associated section of the color comparator bar. A sample with a pH 7 may exhibit a brownish-yellow color reading instead of the expected olive green color. The issue was first reported by a US account in March 2015 but the issue was escalated due to trending observed in January 16.

12 HC Recall 02/05/16

Philips Medical Systems

(Cleveland) Inc.

595 MINER ROAD

CLEVELAND

Ohio UNITED STATES

A. BRILLIANCE 40/64 SLICE CT

SYSTEM B. BRILLIANCE ICT SYSTEM-

SYSTEM C. BRILLIANCE ICT SP SYSTEM-

MAIN D. INGENUITY CT SYSTEM

IMR cardiac - irregular appearance of contrast in vessels, missing image annotation's in cct, halo artifacts, incorrect Z annotation on plan box for coronal/sagittal surviews, unintended change of acquisition timing on scan ruler, bolus tracker does not trigger as expected, system unresponsive when paused, system becomes unresponsive during timed scan, unplanned results during multi-phase pulmo series, may cause a system crash, communication errors between host computer & gantry, incorrect phase tolerance for cardiac step & shoot, error when auto ROI placement outside patient anatomy, no "go" when HR is outside of acceptable range, console unresponsive when gantry cancels scan, unable to match Z locations on prescan and 4D CT scan, pin wheel artifact using 0.67mm slice width, tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall)

13 HC Recall 02/05/16 Pulpdent

CorporatioOpaquer

Opaquer does not have a Health Canada license and was sold into Canada through a

n

80 OAKLAND

STREET P.O. BOX

780

WATERTOWN

02472

Massachusetts

UNITED STATES

clerical error.

14 HC Recall 02/05/16

AGFA Healthcare

N.V.

Septestraat 27

Mortsel 2640

BELGIUM

DX-D 600 There is a potential of an unsecured mechanical detent marker of the DX-D 600 system.

15 HC Recall 02/05/16

Beckman Coulter

Inc. 250 S.

Kraemer Blvd.

92821 UNITED STATES

A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM B. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

Beckman Coulter has confirmed an issue where the Red Blood Cell (RBC) aperture baths can contain residue in the sweep flow fittings. This residue may potentially create increased background failures, flagged results and vote outs for RBC and platelet (plt) parameters.

16 HC Recall 02/05/16

Bard Access Systems

Inc. 605 North 5600 West Salt Lake

City

REPLACEMENT CONNECTOR,GROSHONG NXT

PICC REWG1375, REWJ1000, REXA1014, REXE1882

Bard is informing customers that the case label for specific lots of the replacement connector for Groshong NXT PICC (product code 7812500 only) incorrectly identifies the connector colour as "white", whereas the connector is red and is correctly identified by the unit label as red. No

84116 Utah

UNITED STATES

product return is required.

17 HC Recall 02/05/16

Siemens Medical

Solutions USA Inc.

685 East Middlefield

Road California UNITED STATES

ACUSON SC2000 ULTRASOUND - OPERATING SOFTWARE

While imaging with a transesophageal (TEE) transducer (z6ms, v5ms, or v7m), the operator may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-Mode cursor, the 2D field of view, or the res region of interest with the trackball.

18 HC Recall 02/05/16

Immucor Transplant Diagnostics

, Inc. 550 West

Avenue Stamford

06902

Connecticut

UNITED STATES

Lifecodes HLA-C eRES SSO Typing Kit

It has been determined that the threshold set for HLA-C eRES probes 380, 382, 384 and 385 are set high and may result in false negative probe results. The probes resolve the following CWD alleles probe 380 resolves c*03:06, probe 382 resolves c*12:13, probe 384 resolves c*01:08 and probe 385 resolves c*08:06.

19 HC Recall 03/05/16

PHILIPS HEALTHCA

RE (SUZHOU) CO., LTD NO. 258, ZHONG YUAN ROAD

SUZHOU 215024 CHINA

DURADIAGNOST

A firmware anomaly inside the detector (PX4343RG) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not, resulting in not correctly acquiring the x-ray image.

20 HC Recall 04/05/16 Olerup SSP

AB OLERUP SSP HLA-A

In kits of A*01, lots 41V, 35X and 83Y, the A*01:04N allele is not amplified by primer-

Franzengatan 5

Stockholm, Sweden,

11251

mix 5 as stated in product documentation. The false negative amplification for the A*01 kit yields a revised reactivity pattern for the A*01:04n allele that is identical to A*01:01 alleles.

21 HC Recall 04/05/16

Alcon Laboratorie

s Inc. 6201 South

Freeway Fort Worth

Texas UNITED STATES

A. CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS

PACK, BASIC B. CENTURION VISION SYSTEM

- ACTIVE IRRIGATION FMS PACK, INFUSION SLEEVES

C. CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, W/INTREPID ULTRA

SLEEVES

Alcon Canada is conducting this voluntary medical device removal for specific lots of CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration leur which may result in a reduction of vacuum within the aspiration line.

22 HC Recall 04/05/16

Siemens Healthcare Diagnostics

Inc. 511

Benedict Ave

Tarrytown 10591

New York UNITED STATES

A. ADVIA CENTAUR SYSTEM-TROPONIN I ULTRA (TNI-

ULTRA) ASSAY B. ADVIA CENTAUR CP SYSTEM-

TROPONIN I ULTRA (TNI-ULTRA) ASSAY

An urgent field safety notice (UFSN) has been issued by Siemens informing the customers of the biotin interference in the ADVIA Centaur TnI-Ultra assay. In date lots of ADVIA Centaur TnI-Ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). The instructions for use states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin demonstrate =10% change in results.

23 HC Recall 05/05/16

Smiths Medical ASD, Inc.

1265 Grey Fox Road St. Paul 55112

Minnesota UNITED STATES

A. CADD ADMINISTRATION SETS WITH FLOW STOP

Smiths is notifying users of CADD Administration Sets with flow stop that these listed sets may affect flow rate when used with a variety of CADD ambulatory infusion pumps. This may result in under-delivery of medication by an average additional 5.2% beyond the labeled system delivery accuracy claim of +/- 6.0%. If drug under-delivery occurs, patients may not receive their full volume of medicinal product in the prescribed timeframe.

24 HC Recall 06/05/16 Roche

Diagnostics GMBH

TRIGL (TRIGLYCERIDES) FOR COBAS C701 ANALYZER

The manufacturer has identified during an internal investigation on a unique customer complaint, that a change in the Cobas C701-

Sandhoferstrasse 116

Mannheim 68305

GERMANY

702 application prozone limit check was required for the triglycerides assay to address a potential for low results without the expected flag. The application package has been modified and has been provided accordingly to add the new prozone limit check.

25 HC Recall 06/05/16

Cordis Corporatio

n 14201 NW 60TH AVE.

MIAMI LAKES 33014 Florida UNITED STATES

A. PRECISE PRO RX NITINOL STENT SYSTEM - 20MM

B. PRECISE PRO RX NITINOL STENT SYSTEM - 30MM

C. PRECISE PRO RX NITINOL STENT SYSTEM - 40MM

Based on recent complaints and subsequent investigation, Cordis has determined that products made between April 27, 2015 and November 22, 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. Product manufactured after November 22, 2015, including product currently manufactured and supplied are not affected. There have been no patient injuries reported to us related to this issue. However, considering the products risk analysis the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared, vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment, or in most severe cases, transient ischemic attack or stroke.

26 HC Recall 06/05/16

Zimmer Inc. 1800 West

Center Street

Warsaw 46580

UNITED STATES

A. COMPRESSION SCREW B. MAGNA-FX CANNULATED

SCREW FIXATION SYSTEM AND INSTRUMENTATION

C. TRILOGY ACETABULAR SYSTEM-BONE SCREWS

D. COMPRESSION SCREW

These screws are packaged with a double barrier system, two plastic trays and two Tyvek lids, to provide sterile integrity. Process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray. The holes were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. The outer tray is not affected and the device's sterile

integrity remains until the outer tray is opened. No product complaints have been reported for this issue.

27 US Recall 02/05/16

Siemens Medical

Solutions USA, Inc.

685 E Middlefield

Rd Mountain View CA 94043-4045

ACUSON SC2000 Ultrasound imaging system with software

version VB10C and using transesophageal (TEE)

transducer Z6Ms, V5Ms or V7M.

While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.

Under Siemens update program US013/16/S a Customer Advisory Notification will be mailed to all affected customers by Certified mail with return receipt beginning March 30, 16. Letters provide customers information on how to avoid the issue until the software patch is installed.

Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.

28 US Recall 02/05/16

Radiometer America Inc

250 S Kraemer

Blvd Brea CA 92821-6232

TCM CombiM

Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

RadioMeter sent an Product Notification letter out on November 18, 2015, January 10, 16 and March 29, 16. The notification sent on November 18, 2015 and January 10, 16, instructed customers a temporary solution of switching off the analyzer and then on again in order to re-establish the pre-set alarm volume. If alarm sound is higher than the pre-set volume customers are instructed to contact their local Radiometer service representative. If any questions contact Radiometer America Technical Support at 1-800-736--600 opt. 4. The notification sent on March 29, 16, provided the same instructions and temporary solution. The notification also informed customers that the firm will be in contact with them to discuss the upgrade process.

Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar,

Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.

29 US Recall 02/05/16

Carestream Health Inc

150 Verona St

Rochester NY 14608-

1733

CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191,

DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4

Bundles: IMAGESUITE STANDALONE PACS:

REF/Catalog # 1741289, IMAGESUITE STANDALONE

PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO

(Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO

Wireless System Laptop: REF/Catalog # 1741925, PRO

Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered

System Desktop: REF/Catalog # 1741941, PRO Tethered

System Laptop: REF/Catalog # 1741958, PRO Tether System -

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

Carestream Health sent an URGENT MEDICAL DEVICE CORRECTION letter dated April 6, 16, and Consignee Notification Acknowledgement form to the US consignees on April 15, 16, via Certified Mail, Return Receipt Requested. Foreign consignees are being notified based on the individual country regulations. Customers who have this Image Suite configuration but do not use it for CT or MR Imaging do not need to take any action. Customers who use the product for CT or MR Images are asked to make users aware of the problem and take additional steps to check correct orientation of any markers, until the software is updated. Customers with questions or concerns were instructed to contact the Carestream Customer Care Center in the US at 1-800-328-2910. Customers outside the US were instructed to contact their local Service Support number. For questions regarding this recall call 1-800-328-2917.

NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti,

w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog #

1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO

Wireless System Laptop: REF/Catalog # 1742006, PRO

Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered

System Desktop: REF/Catalog # 1742022, PRO Tethered

System Laptop: REF/Catalog # 1742055, PRO Tether System -

w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY

14608 --- CLASSIFICATION NAME: System, Image Processing,

Radiological The Carestream Image Suite

System is an image management system whose intended use is to receive,

process, review, display, print and archive images and data from CR and DR modalities.

This excludes mammography applications in the United

States

France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay,

Uzbekistan, Vietnam.

30 US Recall 02/05/16

Carestream Health Inc

150 Verona St

Rochester NY 14608-

1733

CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-

PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-

PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street,

Rochester, NY 14608 --- CLASSIFICATION NAME:

System, Image Processing, Radiological

The Carestream Image Suite System is an image

management system whose intended use is to receive,

process, review, display, print and archive images and data from CR and DR modalities.

This excludes mammography applications in the United

States.

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

Carestream Health sent an URGENT MEDICAL DEVICE CORRECTION letter dated April 6, 16, and Consignee Notification Acknowledgement form to the US consignees on April 15, 16, via Certified Mail, Return Receipt Requested. Foreign consignees are being notified based on the individual country regulations. Customers who have this Image Suite configuration but do not use it for CT or MR Imaging do not need to take any action. Customers who use the product for CT or MR Images are asked to make users aware of the problem and take additional steps to check correct orientation of any markers, until the software is updated. Customers with questions or concerns were instructed to contact the Carestream Customer Care Center in the US at 1-800-328-2910. Customers outside the US were instructed to contact their local Service Support number. For questions regarding this recall call 1-800-328-2917.

NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia,

Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.

31 US Recall 03/05/16

Siemens Medical

Solutions USA, Inc

40 Liberty Blvd

Malvern PA 19355-1418

MAGNETOM Aera/Skyra Systems, whole body magnetic

resonance imaging systems, Model numbers 10432914,

10432915. Docking station top cover (part no# 10591430) of the removable patient table.

The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.

Siemens mailed to customers on April 13, 16, a Customer Safety Advisory Notice, MR013/16/S, to inform them of the actions to take to prevent a possible hazard to persons and equipment. Customers were informed that they will be contacted by one of Siemens' service organization who will schedule an appointment to perform a correction, which is to exchange the top cover.

US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.

32 US Recall 03/05/16

Nuvectra 10675

Naples St NE

Blaine MN

Nuvectra, Algovita Spinal Cord Stimulation System Clinical

Programmer, Model 4500. For use with Algovita Spinal Cord

Stimulation Systems. The

If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user

Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 16 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.

Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 16 to

55449-5802

version of the software in the Clinician Programmer is v1.1.5.

The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more

leads inserted into the patient¿¿"s spinal epidural

space. The lead delivers electrical stimulation

originating at the stimulator with the purpose of blocking

pain signals going to the patient¿¿"s brain. The

stimulators are rechargeable, and the frequency of

recharging is dependent on individual patient¿¿"s use of

the system. The Clinician Programmer (CP)

is a hand-held, touch screen device used to create and

adjust stimulation parameters that are developed to optimize the therapy for each patient.

The CP communicates with the stimulator via the Medical Implant Communication

Service (MICS). The CP wirelessly transfers the stimulation parameters to the

stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs

and IPGs

being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.

customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.

33 US Recall 03/05/16

Fujifilm Medical Systems

U.S.A., Inc. 419 West

Smart CR Digital Computed Radiography System; Model

Number: CR-IR346RU

Reports of failure of the device's power supply.

Fujifilm sent an Medical Device Correction letter dated March 22, 16, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a

Nationwide Distribution.

Ave

Stamford CT 06902-

6343

field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.

34 US Recall 03/05/16

Alcon Research,

Ltd. 6201 South

Fwy Fort Worth TX 76134-

2099

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716,

8065751717, 8065751718, 8065751720, 8065751721,

8065751723. An ophthalmic microsurgical

system indicated for phacoemulsification and

removal of cataracts.

The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.


35 US Recall 03/05/16

Biomerieux Inc 595

Anglum Rd Hazelwood MO 63042-

2320

VITEK 2 Gram Positive Susceptibility Test Cards (AST-

P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc,

Durham, North Carolina 27712. VITEK 2 is an automated

system consisting of instruments, software, and

reagent cards designed for the identification and antimicrobial

susceptibility testing of bacteria and yeast. The VITEK 2

utilizes growth-based biochemical patterns to

determine identification. The VITEK 2 provides minimal

inhibitory concentration (MIC) results for most organism/drug

combinations as well as a category interpretation (S, I, or

R) consistent with accepted criteria. The VITEK 2 System is

not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the

patient. The VITEK 2 Gram Positive Susceptibility Card is

intended for use with the

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 16, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. ¿ For the referenced test kit (VITEK¿ 2 AST P605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory.¿ o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK¿ 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new AST P605 lot number. Customers were instructed tostore the letter with their bioM¿rieux instrument documentation. ¿ Complete the attached Acknowledgement Form and return it to their local bioM¿rieux representative. For questions regarding this recall call 314-731-8526.

Worldwide Distribution to China Taiwan region; No US/military/government distribution.

VITEK 2 Systems in clinical

laboratories as an in vitro test to determine the susceptibility

of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial

agents when used as instructed in the Product Information

manual.

36 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Dialog A + HE/BIC

Product Code 710200L Serial # >200318 and <

2039222 The Dialog+ can be used for

implementing and monitoring hemodialysis treatments for

patients with acute or chronic kidney failure. The system can

be used in hospital, health center and outpatient dialysis

center settings when prescribed by a Physician. The

following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or

without phases of pure ultrafiltration, High flux

hemodialysis and low flux hemodialysis.

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

37 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Dialog A + 1 Blood

Pump 120V Product Code 710200K

Serial # >202169 and < 203249 The Dialog+ can be used for



be used in hospital, health


B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico,

center and outpatient dialysis





accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

and St. Thomas USVI

38 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Dialog + 120 V

DF+Adimea+WAN-BSL Product Code # 710200S

Serial # >200805 and <204001 The Dialog+ can be used for









B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.


39 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Conductivity Sensor

(BIC) Item # 3456102A The Dialog+ can be used for





B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT,






Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

40 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Conductivity Sensor

(BIC) Item 3456103A The Dialog+ can be used for









B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717


41 US Recall 03/05/16

B Braun Medical Inc

824 12th Ave

Bethlehem PA 18018-

3524

Dialog+ Hemodialysis machines: Dialog + 120 V

DF+Adimea+WAN-BSL-BIC Product Code # 710200U

Serial # 202136 and < 203837 The Dialog+ can be used for





B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico,






accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

and St. Thomas USVI

42 US Recall 04/05/16

Medtronic Inc.,

Cardiac Rhythm

and Heart Failure

8200 Coral Sea St NE Mounds View MN 55112-4391

Medtronic CareLink" Monitor (2490C) and Medtronic

CareLink Express" Monitor (2020B)

Product Usage: The 2490C CareLink Home

Monitors and 2020B CareLink Express Monitors are remote

monitoring systems that interrogate implanted devices

and transmit the data to Medtronic s CareLink Network

for viewing by the physician. The data is transmitted either through an analog telephone

line, a cellular connection or an internet connection.

A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou

Medtronic sent an "Urgent Field Safety Notice" dated April 16to their customers. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and customer actions to be taken. For questions contact your local Medtronic Representative.

AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.

43 US Recall 04/05/16

Siemens Medical

Solutions USA, Inc

40 Liberty Blvd

Malvern PA 19355-1418

Syngo Dynamics; Kinetdx Picture Archiving and

Communications System

Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.

Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI

44 US Recall 04/05/16

Toshiba American Medical

Systems Inc

Toshiba American Medical Systems Celesteion, Item Code:

PCA-9000A/2, 9000A/3B, 9000A/2B

Potential degradation of detector performance.

Toshiba sent an Urgent Medical Device Correction letter dated April 24, 16 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion

US Distribution to WI and NV.

PO Box 2068 2441

Michelle Dr Tustin CA

92780-7047

This system is designed to acquire CT images, PET images,

and fusion images (superimposed PET and CT

images). The images that can be acquired include planar

images (for any position and from any direction) and

volume images (3D images) of the whole human body

(including the head). The CT images provide morphological

information showing the positional relationships between the lesion and

adjacent tissues, while the PET images provide functional information based on the

uptake of the injected radioisotope.

PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to [email protected]. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

45 US Recall 04/05/16

Ferno-Washingto

n Inc 70 Weil

Way Wilmington OH 45177-

9371

Poly-bags containing the strap labeled with "Adult" sticker.

Each strap kit contains adjustable length leg straps,

ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint

frame to immobilize and provide traction for a patient s

leg.

On March 9, 16, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled Pediatric conta

Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 16. All products will be replaced with new products. For further questions, please call: (937) 283-2885.

Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and

to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA.

46 US Recall 04/05/16

Medtronic Sofamor

Danek Usa, Inc - Dallas Distribution

4620 N Beach St

Haltom City TX 76137-

3219

Medtronic Midas Rex Dissecting Tool Legend 10 cm

4mm BA DIAM. Intended for use in

neurosurgery.

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

A notification letter was provided to each consignee, translated as necessary, on April 8, 16.

Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.

47 US Recall 04/05/16

CareFusion 303, Inc. 10020 Pacific

Mesa Blvd San Diego CA 92121-

4386

Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for

the Alaris System.

The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.

The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 16 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by email at [email protected]. Customers with clinical inquiries, product complaints, or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7 days/week or by email at [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PST, M-F or by email at [email protected].

Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.

48 US Recall 04/05/16 Ferno-

Washington Inc

Poly-bags containing splint strap labeled with "Pediatric"

sticker.

On March 9, 16, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction

Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 16. All products will be replaced with new products. For further questions, please call: (937) 283-

Worldwide Distribution - US Distribution

70 Weil

Way Wilmington OH 45177-

9371

Each strap kit contains adjustable length leg straps,

ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint

frame to immobilize and provide traction for a patient s

leg.

splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled pediatric cont

2885. to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA.

49 US Recall 05/05/16

Applied Medical

Technology Inc

8000 Katherine

Blvd Brecksville OH 44141-

4202

TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx

ONLY (USA) STERILE EO Do Not Resterilize.

Product Usage: Indicated to aid in tissue

retraction during a surgical procedure.

The firm received a complaint of an open pouch which breaches the sterilization validation.

AMT sent an Urgent Medical Device Recall letter dated February 17, 16 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.

Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the

following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

50 US Recall 05/05/16

Applied Medical

Technology Inc

8000 Katherine


4202

Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile

Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE

EO Do Not Resterilize Product Usage:

Indicated to aid in tissue retraction during a surgical

procedure.



Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

51 US Recall 05/05/16

Applied Medical

Technology Inc

8000 Katherine

Blvd Brecksville

Wilson Implantation System Product Usage:

Indicated to aid in tissue retraction during a surgical

procedure.



Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO,

OH 44141-

4202 NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

52 US Recall 05/05/16

Applied Medical

Technology Inc

8000 Katherine


4202

TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR

FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY

Product Usage: Indicated to aid in tissue

retraction during a surgical procedure.



Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

53 US Recall 06/05/16 Covidien

LLC Given Imaging Bravo¿¿ pH

capsule delivery device, 1-pack. Potential of an allergic reaction in a patient with nickel sensitivity.

The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/16 to its Customers via Federal

Worldwide Distribution: US

60

Middletown Ave North

Haven CT 06473-3908

In- Vitor Diagnostic for pH monitoring of gastric reflux

Item Number: FGS-0313 The Bravo pH Monitoring

System is intended to be used for gastroesophageal pH

measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be

attached following either endoscopy or manometry. The RAPID pH software is intended

to record, store, view, and analyze gastroesophageal pH

data.

Express. The letter describes the product, problem and actions to be taken. The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance [email protected] or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo¿ pH monitoring system User Manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. "The Bravo capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. The Bravo¿ pH test lasts from 48-96 hours." If you have any questions, please contact Technical Service at 1-800-448-3644, option 3.

(nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.

54 US Recall 06/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Syva Emit Methotrexate Assay, is a homogeneous enzyme

immunoassay intended for use in the quantitative analysis of

methotrexate in human serum or plasma.

Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.

Siemens mailed an Urgent Medical Device Correction letter to customers informing them that they were withdrawing the Emit Methotrexate Application on the Dimension Vista System. Customers were asked to contact their local Siemens sales representative for alternative testing solutions for Methotrexate. Siemens advised customers to change the On-Board Stability for the Methotrexate application on the Dimension Vista System to four hours: alternatively, customers can run the Methotrexate application in batch mode, along with QC. It was also requested in the notification that customers complete and return the Field Correction Effectiveness Check Form that was attached with the notification within 30 days.

Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.

55 US Recall 06/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent

cartridge The BUN method is an in vitro

diagnostic test for the quantitative measurement of urea nitrogen (an end product

of nitrogen metabolism) in human serum, plasma, and

Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.

Siemens Healthcare sent an Urgent Medical Device Correction letter dated February 16, to all affected customers. It was determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15299BB, 15300BA, 15320BB and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagent cartridges manufacture from specific mold/cavity identifies as described in Table 2 of the Urgent Medical Device Correction notification sent to customers.

Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE,

19702-2466

urine on the Dimension Vista System.

Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.

FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.

56 US Recall 06/05/16

Applied Medical

Resources Corp

22872 Avenida Empresa Rancho Santa

Margarita

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in

laparoscopic and general surgical procedures.

Distributed individually and in kits.

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to

U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO,

CA 92688-

2650 (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at [email protected].

CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia

57 US Recall 06/05/16 Atlas Spine,

Inc. 1555

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089

Model # ITN-001-000

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return

Nationwide Distribution to FL, MO, and

Jupiter Park

Dr Ste 4 Jupiter FL

33458-8085

Used to rotate implant into position

and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102.

WV.

58 US Recall 06/05/16

C.R. Bard, Inc.

8195 Industrial Blvd NE

Covington GA 30014-

1497

Arctic Sun Temperature Management System, 5000,

100-120V and 220-240V The product is a thermal

regulating system indicated for monitoring and controlling

patient temperature

The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.

BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email [email protected]. For questions regarding this recall call 770-784-6220.

Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman,

Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom

59 US Recall 06/05/16


, Inc. 511

Benedict Ave

Tarrytown NY 10591-

5005

ADVIA Centaur CP Immunoassay System, Siemens

Material Number (SMN) 10309710, IVD. ---

CLASSIFICATION NAME: Immunoassay Analyzers.

This system is intended for professional use in a laboratory

environment only. Tests performed using this system

are intended for in vitro diagnostic use.

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operator s Guide.

Siemens sent an Urgent Medical Device Correction letter dated March 16, to all affected customers. The letter was sent to the US customers via Fed Ex beginning on March 30, 16., and were e-mailed dated March 20, 16, to regional countries for implementation outside the US. Field service personnel were sent a support bulletin describing the issue and instructing them how to manage customer questions. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please review this letter with your Medical Director. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (914) 524-2868.

Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India,

Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.

60 SA Recall 04/05/16

Philips Healthcare (Additional details are provided in

DigitalDiagnost systems

A firmware anomaly inside the detector (4343RC) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not, resulting in not correctly acquiring the X-ray image.

Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented.

the

attachment)

61 SA Recall 04/05/16

AB SCIEX Pte. Ltd

(Additional details are provided in

the attachment

)

4500MD Mass Spectrometer

An issue has been identified with a small number of 4500MD LC/MS/MS Systems where under certain conditions, there is the possibility that a user will be presented with incorrect quantitative results.

Short term field corrective actions: •Affected units in Distribution Centers (Dallas and Netherlands) and Singapore manufacturing site have been quarantined. Units in Distribution Centers have been shipped to Singapore to conduct re-work.

62 SA Recall 04/05/16

Philips Healthcare (Additional details are provided in

the attachment

)

MX 16-slice CT Systems

The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function. (The issue will not occur on the following scan if any helical scan has been executed after system startup.)

Until the software is upgraded to v1.1.4.21428, follow the directions below to avoid the issues described in the FSN. Issue 1: When the copy and paste operation is used to edit patients’ films, ensure the patient image is copied from the current patient before pasting to the film. Check the patient information on the image and ensure the desired images are copied onto the film. Issue 2: When performing a Bolus Tracking scan, do not use the Auto Voice option in Tracker scan. Use the intercom to give breathing instructions to the patient during Bolus Tracking scan. Issue 3: If the SAS option is displayed on the Contrast tab of the scan protocol parameter area, but is not enabled, enable the SAS option manually. If the SAS option is not displayed, select another series and then select back to the series of Helical scan. The SAS option will be displayed and then the clinician can enable the SAS option manually. A Philips Field Engineer will contact you to schedule this correction to upgrade the software free of change.

Nr AUT MEAS DATE MFR DVC BACKGROUND/REASON ACTIONS/INSTRUCTIONS DISTRIBUTION

LIST

1 AUS Recall 09/05/16 Boston

Scientific Threader Monorail and

Threader Over the Wire Micro-Boston Scientific has determined that certain Threader Monorail and Threader

Recall for Product Correction - Boston Scientific is providing users with the Australian DFU.

Pty Ltd Dilatation Catheters (used

during angioplasty procedures):

A. Threader Monorail Micro-Dilatation Catheter

B. Threader Over the Wire Micro-Dilatation Catheter

Over the Wire Micro-Dilatation Catheters were shipped from the Australia distribution centre with an International Direction for Use (DFU) rather than an Australian DFU. The Australian DFU includes additional warnings and precautions included in the ‘Precaution’ section of the DFU.


Sanofi-Aventis

Australia Pty Ltd

Rifadin IV 600mg (Rifampicin B.P. 600mg powder for I.V.

infusion and diluent)

Sanofi-Aventis Australia Pty Ltd, is recalling batch number A5548 of Rifadin IV 600mg (Rifampicin B.P. 600mg powder for I.V. infusion and diluent) following an investigation of out of trend results indicating the product was contaminated with chilled water circulating in the jacket of the reactor during manufacture.

Recall - Hospitals and pharmacies are advised to return remaining inventory of the affected batch to the wholesaler it was purchased from. Wholesalers are advised to return the affected batch to Sanofi.


Alcon Laboratories Australia

Pty Ltd

Centurion FMS (Fluidics Management System) Pack

(used to control irrigation and aspiration in the eye during

cataract surgery)

Alcon is conducting a recall for specific lots and catalogue numbers of its CENTURION FMS (Fluidics Management System) Pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. The use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip. There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. There have been no reports of injuries associated with this issue.

Recall - Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected product.

4 AUS Recall 10/05/16 Life

Healthcare Pty Ltd

Volcano S5, S5i, CORE, CORE Mobile Systems with software

versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical

defects of the heart or problems associated with

myocardial infarction)

The manufacturer, Volcano Corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. In specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually

Recall for Product Correction - LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction.

rebooted. This condition can occur any time, including in the middle of a patient procedure. The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. If this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of IVUS and FFR/iFR functionality in the procedure. There have been no reports of injuries associated with this issue.


Thermo Fisher

Scientific Australia &

New Zealand

RAPID Hp StAR Kit (used in the detection of H. pylori). An in

vitro diagnostic medical device (IVD)

An internal technical investigation by Oxoid Limited, has identified that the affected lot may give a weak false positive line with no H. pylori antigen present, making interpretation of test results more difficult than with previous batches. Continued use of this lot may result in a delayed or false positive results reporting.

Recall - Thermo Fisher is advising users to inspect stock and remove any remaining product of the affected lot number from use. A credit note will be issued. A review of previously generated patient results is at the discretion of the Laboratory Director.


Beckman Coulter

Australia Pty Ltd

Multiple Assay for Enzymatic Creatinine, Cholesterol,

Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic

medical device (IVD)

There is a possibility that drug interferences from administration of Metamizole (Dipyrone) to patients may generate false low results. Metamizole (Dipyrone) has been identified as an interferent which may cause false low results in certain assays. This is a previously undocumented interferent. These interferences are based on a chemical interaction with the Trinder reaction, similar to NAC interference previously identified by Beckman Coulter and may result in an error in diagnosis or patient management. No customer complaints have been received for this particular issue.

Recall for Product Correction - Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences. A review of previously generated patients results is at the discretion of the Laboratory Director.

7 AUS Alert 11/05/16 Heartware

Pty Ltd

HeartWare HVAD system All HeartWare Controllers

affected

HeartWare have received reports of loose power and data connectors on the HeartWare Controller, specifically for loose connector ports within the Controller.

Hazart Alert - HeartWare is advising the clinicians to: 1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and

If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures. In these scenarios, potential risks include: - Interruption of circulatory support due to a pump stop, which could cause serious injury or death - Reduced ability to detect alarms - Loss of communication between the Controller and HeartWare Monitor.

carefulness when connecting and disconnecting to power and data sources. 2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector.


Johnson & Johnson

Medical Pty Ltd t/a DePuy

Synthes

Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure

Titanium

The affected part and lot numbers of the 4.5mm Cortex Screws, length 20mm, may contain a 4.5mm Cortex Screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers. The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. If detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it. In addition, the potential harm of Damage to Surrounding Structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. A screw that is too long can also result in Soft Tissue Damage (Soft Tissue Irritation) if not recognised during the procedure. At this time there have been no reports of patient involvement.

Recall - JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number.

9 AUS Recall 11/05/16 Johnson & Cordis PRECISE PRO RX Nitinol Based on complaints and a subsequent Recall - Users are asked to immediately identify and

Johnson

Medical Pty Ltd

Stent System (Carotid) investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member. The reported issues may result in an intra-procedural delay for the patient while a replacement device is prepped. Partial stent deployment may result in vessel damage (carotid dissection or perforation, vessel spasm) requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment. In most severe cases, partial stent deployment may potentially result in Transient Ischaemic Attack or stroke. Cordis have isolated the issue to product manufactured between 27 April 2015 and 22 November 2015. Product that has been manufactured after 22 November 2015 is not affected.

quarantine all products listed in the customer letter in a manner that ensures the affected products will not be used and to complete the attached acknowledgement form, follow the instructions given and to forward this notice to anyone in your facility that needs to be informed.


Healthcare Pty Ltd

TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac

troponin). An in vitro diagnostic medical device (IVD)

Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA

Centaur CP

Siemens Healthcare Laboratory Diagnostics has confirmed that all in date lots of ADVIA Centaur TnI-Ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). The Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin demonstrate = 10% change in results. The biotin level in a general population is approximately 0.3 to 1.0 ng/mL (1.2 to 4.3 nmol/L). The biotin interference is proportionate across TnI concentrations; therefore, the ability of the assay to detect serial increases or decreases of TnI is maintained.

Recall for product correction - Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained. A review of previously generated results is at the discretion of the Laboratory Director.

11 AUS Recall 12/05/16 GE

Healthcare Australia

Revolution CT (diagnostic x-ray system)

GE Healthcare has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended

Recall for product correction - GE Healthcare is advising users to continue to use the Revolution CT system, and ensure the warnings regarding Patient Positioning in the IFU are

Pty Ltd motion in cases involving large patients. The

Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injuries have been reported to date related to this issue.

followed. GE will be correcting all affected systems.


Schell Medical

Corporation Pty Ltd

Resus-EZY Manual Resuscitator (single-use pulmonary

resuscitator)

There have been some reported cases where the Flow Diverter used in these products is being cracked. The Flow diverter is the blue adaptor that attaches to the Patient Valve. The Flow Diverter directs the patient’s exhaled breath to atmosphere or into a PEEP (Positive End Expiratory Pressure)Valve where a PEEP Valve is being used. A cracked Flow Diverter can affect the PEEP Valves ability to hold PEEP. As the Flow diverter is on the expiratory side of the breathing system there is no effect on the Resuscitators ability to deliver gas to the patient. Additionally, in the event of a cracked Flow Diverter, there are two discrete one way valves isolating the expiratory side from the Inspiratory side. Thus there is no pathway by which any foreign material could enter the inspiratory side of the resuscitator. A cracked Flow Diverter has no affect upon the Resuscitators ability to deliver gas to the patient.

Recall - Schell Medical is advising users to inspect stocks for the affected lot numbers. If any of the impacted products show signs of cracking, quarantine for return and replacement by Schell as per normal procedures.



Ltd

MX 16-slice CT x-ray systems with software version

v1.1.4.21426.

The following issues have been found in MX 16-slice systems. 1) During the filming operation, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2) During the Bolus Tracking scan, if the

Recall for product correction - Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3) If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function. There have been no reports of injuries.

14 AUS Recall 12/05/16 Diagnostic Solutions

Pty Ltd

LIFECODES HLA-C eRES SSO Typing Kit. An in vitro

diagnostic medical device (IVD)

It has been determined that the threshold set for HLA-C eRES Probes 380, 382, 384 and 385 in Lot Number 10235B are set high and may result in false negative probe results. The probes resolve the following CWD alleles: • Probe 380 resolves C*03:06 • Probe 382 resolves C*12:13 • Probe 384 resolves C*01:08 • Probe 385 resolves C*08:06

Recall for Product Correction - Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot.



Ltd

Brilliance iCT and iCT SP, with software versions v4.1.3 and

v4.1.5

The following issues have been identified which may result in additional patient scanning & therefore additional radiation doses. There have been no reports of injuries as a result of these issues; - Scan length changes with a change in the field of view (FOV); - The DoseRight algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kVp or 120 kVp surview is used. This will result in a mAs value for the scan that is higher than suggested when using a 100 kVp or 140 kVp surview. (Note: The reported mAs and CTDI values are correct for all scans & surviews); - Wrong scan time estimation due to incorrect intergration time causes the

Recall for Product Correction - Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

SurView scan near 184mm &135mm may result in unexpected scan start positions; & - There may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. Offline reconstruction of the raw data is also not possible.



Ltd

Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and

Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used

for diagnostic computed tomography scanning)

The following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. There have been no reports of injuries as a result of these issues; - Sagittal result shortened for axial head scans. - When axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of MPR images due to the scan series being broken into serval series of images. - Scan length changes with a change in field of view (FOV). - Scan length changes on subsequent axial results. - Surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions. - There may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. Offline reconstruction of the raw data is not possible.

Recall for Product Correction - Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.


Zoll Medical Australia Pty Ltd

AVOXimeter System (a whole blood oximeter used during

heart catheterisation procedures)

The manufacturer, Accriva Diagnostics has confirmed that some AVOXimeter 1000E instruments shipped to customers from July 2015 and April 16 may have been sent to customers with the diagnostic mode enabled. With the diagnostic mode enabled, users

Recall for Product Correction - Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings.

could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. If these features are altered, there is a potential for erroneous results to be displayed. To date Accriva has not received any reports of injuries or harm to users due to this issue. Instruments in diagnostic mode perform per Accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.


Medline Internation

al Two Australia Pty Ltd

Surgical Clipper Charger

Medline have received reports that due to a potential defective component on the circuit board, the clipper charger can overheat. This could result in a clipper charger malfunction and may cause thermal injuries to the user.

Recall - Medline are advising users to discard the affected chargers. Medline will replace all affected chargers, and is advising users to use an alternative method of hair removal until a replacement arrives.


GE

Healthcare Australia Pty Ltd

MSK 1.5T Extreme and Optima MR430s (MRI Systems)

A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. There have been no injuries reported as a result of this issue. At this site, a magnet heater probe connection became disconnected. This resulted in ice build-up within the magnet blocking the cryogen vent. Since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.

Recall for Product Correction - GE Healthcare is advising users to notify GE Service Engineer if the Magnet Monitoring Unit (MMU) detects any abnormal or out of specification reading. If the Magnet Monitoring Unit (MMU) detects an error it will display a pop-up window on the system monitor which will be seen by the operator. MMU reported errors will be in the form of a CAS7XX error (XX being the specific error) with a brief description. If no Magnet Monitoring Unit errors are reported, there are no action is required. Users can continue normal use of the affected products. GE will be correcting all affected units.



Ltd

DigitalDiagnost Affected Products:

DigitalDiagnost Release 4.0.4, 4.1.2, 4.1.3

A firmware anomaly inside the detector (4343RC) can cause the detector to appear ready for acquisition on very short time intervals while it actual fact it is not ready, resulting in incorrectly acquired X-ray images. If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake the image, leading to additional

Recall for Product Corection - Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact the affected customers when the Field Action Kit is available to be implemented.

exposure for the patient.



Ltd

Brilliance CT and Ingenuity CT systems with software version

v4.1.3 and v4.1.4

On the affected CT systems and software versions, Varian RPM drive is not mapped in CT user profile after logout/login. The Map Drive utility maps the Varian drive using full Varian credentials in the service login and then creates a script that maps it with full Varian credentials in the CT user login. Once the script has run in the CT login and the user acknowledges the drive mapped successfully, the script deletes itself. On subsequent logins, the drive will not connect because the Varian credentials are no longer available. Should this situation occur, the user will be unable to perform pulmonary gated scans.

Recall for Product Correction - Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction.

22 HC Recall 09/05/16

Heartware Inc.

14400 NW 60th

Avenue Miami Lakes

33014 Florida UNITED STATES

A. HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD

IMPLANT KIT

HeartWare has opened an increased number of complaints for loose connector ports within the controller body. In parallel, there has been an increasing trend of customer reports of loose connectors.

23 HC Recall 10/05/16

Baxter Healthcare

Sa Zurich

SWITZERLA

ND

A.COSEAL SURGICAL SEALANT

Baxter is issuing a recall for the product codes and lots listed, due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

24 HC Recall 10/05/16

Oxoid Limited Wade Road

Basingstoke

, Hampshire

A. RAPID HP STAR

Lot HP1115 may give a weak false positive line with no H. pylori antigen present, making interpretation of test results more difficult than with previous batches.

RG24 8PW

UNITED KINGDOM

25 HC Recall 10/05/16

ORTHO-CLINICAL

DIAGNOSTICS

FELINDRE MEADOWS, PENCOED, BRIDGEND

A. VITROS Immunodiagnostic Products AFP Reagent Pack and

Calibrators

Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential of an inability to obtain a valid calibration when using VITROS AFP Reagent Packs: - VITROS Immunodiagnostic Products AFP Reagent Pack, lot 1440 - VITROS Immunodiagnostic Products AFP Calibrators, lot 1440 Ortho confirmed that this lot exhibited an increase in reaction signal over time. Initial testing indicates that the unexpected signal increase is related to a specific lot of raw material used in the manufacture of this lot. The affected lot of VITROS AFP Reagent Packs met all quality assurance specifications upon release.

26 HC Recall 10/05/16

Synthes USA LLC

1101 SYNTHES AVENUE

Monument 80132

Colorado UNITED STATES

A.NORIAN DRILLABLE, CALCIUM PHOSPHATE BONE

VOID FILLER

The rotary pouch within the affected parts and lot numbers may potentially be labelled with the incorrect powder volume/size, however, the rotary pouch contains the correct powder volume/size according to the outer box label.

27 HC Recall 11/05/16

STAAR Surgical

Company 1911

WALKER AVENUE

MONROVIA


A. STAAR Surgical AQ CARTRIDGE-FP

Two (2) affected lots may not perform as intended in that the device may malfunction during use and in rare cases the cartridge may crack during use. One (1) injury was reported during use, an enlargement of the incision, with no further adverse patient impact.

28 HC Recall 11/05/16 Pulse A.ID-FUNGAL ANTIBODY This product was found to have bacterial

Scientific

Inc. 5100 South Service RD,

Unit 18 Burlington

L7L 6A5 Ontario CANADA

SYSTEM - HISTOPLASMA contamination.

29 HC Recall 11/05/16

Roche Diagnostics

GMBH


Mannheim 68305

GERMANY

A.FT4 II (FREE THYROXINE II)

In the software screens on cobas e 602, the expiry date of FT4 II reagent kit lot 188609 could be displayed 11/16, instead of the correct date 10/16 which is the expiry date of the box and the reagent kit label. When this occurs, the false expiry date is used with the reagent kits.

30 HC Recall 11/05/16

Zest Anchors, LLC Also

trading as Zest

Anchors, Inc. and

Zest Anchors

2061 WINERIDGE

PLACE,

ESCONDIDO


A. LOCATOR Abutments and Collars for Multi-Unit Assembly

The LOCATOR Abutment and Collar for multi-unit assembly (p/n 08909-2) has a specified quantity of 2 units in a package. It has been found that these products were provided with only one vial instead of two as designated by the "-2" suffix in the product's part number, which is included on the product label.

31 HC Recall 11/05/16

Datascope Corp.,

15 Law Drive,

Fairfield

A. MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion

Kit & STATLOCK

It was discovered during post-quarantine packaging on February 16, 16 that the IFU for the StatLock Sheath Stabilization device for Percutaneous Sheath Introducers (incorrect IFU) was erroneously packaged

07004

New Jersey UNITED STATES

with the MEGA and SENSATION PLUS IAB Catheter kits, instead of the IFU for the StatLock Catheter Stabilization device for IAB Catheters (correct IFU).

32 HC Recall 12/05/16

GE Medical Systems

LLC 3200 North

Grandview Blvd

Waukesha 53188

Wisconsin UNITED STATES

A. REVOLUTION CT

GE Healthcare has become aware of a potential safety issue in the Revolution CT patient table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm involving the potential impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injuries have been reported to date related to this issue.

33 HC Recall 13/05/16

GE Medical Systems,

LLC 301

BALLARDVALE ST., SUITE 4

WILMINGT

ON 01887

Massachus

etts UNITED STATES

A. OPTIMA MR430S 1.5T - MAIN UNIT

GE Healthcare has recently become aware of a potential safety issue with gas venting. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. There have been no injuries reported as a result of this issue. At this site, a magnet heater probe connection became disconnected. This resulted in ice build-up within the magnet blocking the cryogen vent. Since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.

34 HC Recall 13/05/16


Inc. 500 GBC

DRIVE, MAILSTOP 514, P.O. BOX 6101 Newark

A. DIMENSION VISTA SYSTEM- ENZYME CALIBRATOR

B. DIMENSION CLINICAL CHEMISTRY SYSTEM- ENZYME

II CALBIBRATOR (ENZ II CAL)

C. DIMENSION XPAND SYSTEM-ENZYME II CALIBRATOR

(ENZ II CAL) D. DIMENSION EXL SYSTEM-

Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with specific lots of Dimension Enzyme II Calibrator. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibration lots. The shift began with lot

19714-

6101 Alabama UNITED STATES

ENZYME II CALIBRATOR (ENZ II CAL)

4MDO47.

35 US Recall 09/05/16

Stanmore Implants

Worldwide Ltd. 210

Centennial Avenue

Centennial Park

Centennial Park

Borehamwood United

Kingdom

Distal Femoral Replacement (patient specific, custom made

orthopedic implant device). PIN 19960

Incorrect component used to manufacture distal femoral replacement.

A notification was sent to the prescribing physician on 04/12/16.

US distribution to OH.

36 US Recall 09/05/16

Stryker Sustainability Solutions

1810 W Drake Dr

Tempe AZ 85283-4327

Mallinckrodt Evac Tracheal Tubes

Device packaging may not be sealed.

Customer notification letter was sent 04/04/16. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to [email protected], or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 http://www.stryker.com/productexperience/ The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

US distribution to KY.

37 US Recall 09/05/16


1810 W Drake Dr

Tempe AZ 85283-4327

Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular

system

Device packaging may not be sealed.

Customer notification letter was sent 04/04/16. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to [email protected], or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 http://www.stryker.com/productexperience/ The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

US distribution to KY.

38 US Recall 09/05/16


1810 W Drake Dr

Tempe AZ 85283-4327

Hamilton G5 with software version between v2.41, v2.42,

v2.50. Catalog number: 1590001 and

1590002. Anesthesiology: Hamilton G5

ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and

neonatal patients. The device is intended for use in the hospital and institutional

environment where health care professionals provide

patient care.

After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.

Hamilton Medical Inc. sent an" Medical Device Field Safety Corrective Action" letter dated March 7, 16, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Hamilton Medical then had to compile a list of to whom they had distributed the affected ventilators and sent letters on April 6, 16. Letters included the Medical Device Field Safety Corrective Action from Hamilton AG. Letters included immediate actions to be take by use and that reps will be visiting each site to upgrade ventilators to v 2.60 to alleviate the issue. Distributors will update software and will provide an updated Operator's manual as soon as it is available. Questions may be directed to 800-426-6331, Ext, 215.

US distribution only.

39 US Recall 10/05/16 Siemens

Healthcare Diagnostics

Dimension clinical chemistry system, Sirolimus (SIRO) Flex

reagent cartridge (DF306 SMN

Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when

Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 16, to all affected customers. The letter identified the product the problem and the action needed to

Worldwide distribution and US including

, Inc.

500 Gbc Dr Ms 514 PO BOX

6101 Newark DE

19702-2466

10464331) Lot EB6064, Open Well Instability

The SIRO method is an in vitro diagnostic test for the

quantitative measurement of sirolimus in whole blood on the

Dimension clinical chemistry system.

using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

be taken by the customer. Actions to be Taken by the Customer: Discontinue use of and discard the kit lot listed in Table 1. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.

Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.

40 US Recall 10/05/16

Stryker Corporatio

n 5900

Optical Ct San Jose CA

95138-1400

CinchLock Flex Knotless Anchor with Inserter;

Model number CAT02643; Orthopedic:

The Pivot CinchLock SS Knotless Anchor (CAT02462)

and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant

devices intended for the fixation of soft tissue to bone.

Used for repair of hip, shoulder, foot and ankle,

elbow, wrist and hand and knee.

Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.

Urgent Medical Device Recalls letters were sent on April 12, 16 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.

Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.

41 US Recall 10/05/16

Stryker Corporatio

n 5900


95138-1400

CinchLock SS Knotless Anchor with Inserter;

Model number CAT02462;

Orthopedic: The Pivot CinchLock SS

Knotless Anchor (CAT02462) and Pivot CinchLock Flex

Knotless Anchor (CAT02463) are non-degradable implant

devices intended for the

Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.

Urgent Medical Device Recalls letters were sent on April 12, 16 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.

Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.

fixation of soft tissue to bone.

Used for repair of hip, shoulder, foot and ankle,

elbow, wrist and hand and knee.

Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.

42 US Recall 10/05/16

St Jude Medical

Inc. 15900

Valley View Ct

Sylmar CA 91342-3577

Ellipse ICD (Implantable Cardioverter Defibrillator)

Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C

Product Usage: Ellipse ICD devices are

intended to provide ventricular antitachycardia pacing and ventricular defibrillation for

automated treatment of life-threatening ventricular

arrhythmias.

St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

A customer letter dated 4/7/16 was sent to all customers to inform them that St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. The letter informs the customers that the recall involves information related to 127 units of our Ellipse ICD device distributed worldwide but not implanted in patients. Customers with any questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at 800-722-3774, 24 hours a day, seven days a week.

Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.

43 US Recall 10/05/16

Medtronic 60


Haven CT 06473-3908

Covidien Kangaroo Connect Enteral Feeding Pump

Item Number: 384400 (US) Intended to provide enteral

nutrition to a patient for hospital and acute care

settings.

Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm

Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878.

Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.

44 US Recall 10/05/16

Bradshaw Medical

Inc. 10325 58th

Axial Torque Limiting Driver Product Usage:

The Bradshaw Medical Axial Torque Limiting Driver is a

Bradshaw is recalling 1st Generation Axial Torque Limiting Driver because the firm became aware of a component failure that had the potential to cause a situation where

Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the

US Nationwide Distribution in the states of: CA, FL, IN, MA,

Pl

Kenosha WI 53144-7872

reusable surgical instrument designed to limit the

magnitude of applied (input) torque transferred to an

external (output) device or fastener in the clockwise

direction. The device is a non-adjustable mechanical click style hand torque tool which

presents an audible and tactile click when the maximum desired torque is reached.

the applied torque was significantly higher than the calibrated torque setting.

product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.

MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM

45 US Recall 10/05/16

Ascom US, INC. 300

Perimeter Park Dr Ste

D Morrisville NC 27560-

9703

Ascom Mobile Monitoring Gateway (versions 4.1.1 and

4.2.0) and Ascom Unite Connect for Nurse Call (version

2.2.0).

Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.

On January 4, 16 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 16, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.

CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.

46 US Recall 10/05/16

Medtronic 60


Haven CT 06473-3908

Covidien Kangaroo Connect Enteral Feeding Pump

Item Number: 384400 (US)

Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm

Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic

Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.

representative or Customer Service at (800) 882-5878.

47 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

48 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Dimension Vista Assays: Uric Acid (URCA)




49 US Recall 11/05/20

17


Advia Chemistry Assays - Cholesterol_2 concentrated

and Cholesterol, LDL

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with

Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL,

, Inc.

500 Gbc Dr Ms 514 PO BOX

6101 Newark DE

19702-2466

Cholesterol Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

50 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Advia Chemistry Assay: LDL Cholesterol, Direct




51 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

Dimension Vista Assays: Triglycerides (TRIG)

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-

Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,

6101

Newark DE 19702-2466

Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

52 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

ADVIA CHEMISTRY ENZYMATIC CREATININE_2




53 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA

Chemistry Glucose & Concentrated Glucose Oxidase

Assay and ADVIA Chemistry Glucose.


Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,

specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

54 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Advia Chemistry Assay: Lactate




55 US Recall 11/05/20

17


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2)

REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2

Concentrated (TRIG_c) REAGENT



Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto

Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

56 US Recall 11/05/20

17


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Advia Chemistry Assay: Uric Acid and Uric Acid,

concentrated




57 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Dimension Assays: Direct HDL Cholesterol (AHDL)




58 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Dimension Assays: ENZYMATIC CREATININE




59 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Dimension Assays: Triglycerides (TGL)




60 US Recall 11/05/16


, Inc.

Dimension Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.

Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL,

500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

61 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101 Newark DE

19702-2466

Dimension Vista Assays: Enzymatic Creatine (ECRE)




62 US Recall 11/05/16


, Inc. 500 Gbc Dr

Ms 514 PO BOX

6101

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is

Siemens mailed an Urgent Medical Device Correction letter to customers making them aware of the problem. Special instructions were also given for the customer to review the letter with their Medical Director and ensure Venipuncture occurs before drug administration of NAC or Metamizole as indicated in the letter. Baseline assay values before administration of NAC or Metamizole therapy would not be affected. Customers were asked to complete and return the

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,

Newark DE

19702-2466

the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Field Correction Effectiveness Check Form attached with the letter within 30 days. Furthermore, if customers received any complaints of illness or adverse events associated with the specified lots, they were to immediately contact their local Siemens Customer Care Center or local Siemens technical support representative.

ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

63 US Recall 11/05/16

Biomerieux Inc 595


2320

Vitek 2 Gram Positive Susceptibility Test Cards (AST-

P644 REF 418673), 20 cards/kit.

Product Usage: The VITEK 2 Gram Positive

Susceptibility Card is intended for use with VITEK 2 Systems in

clinical laboratories as an in vitro test to determine the

susceptibility of Staphylococcus spp.,

Enterococcus spp., and S. agalactiae to antimicrobial

agents when used as instructed in the Product Information

manual

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 16 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

64 US Recall 11/05/16

Biomerieux Inc 595


2320


P646 REF 420144), 20 cards/kit.




65 US Recall 11/05/16 Biomerieux

Inc 595


P639 REF 418662), 20


Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 16 to affected customers . The letter identified the affected product, problem and actions to

Foreign distribution in the countries of


2320

cards/kit. be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.

Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

66 US Recall 11/05/16

Biomerieux Inc 595


2320

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit




67 US Recall 11/05/16

Biomerieux Inc 595


2320


P641 REF 418590), 20 cards/kit.




68 US Recall 11/05/16

Biomerieux Inc 595


2320

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit




69 US Recall 11/05/16 Biomerieux Vitek 2 Gram Positive Product insert fails to identify performance Biomerieux sent an Urgent Product Correction Notice letter Foreign

Inc 595


2320

Susceptibility Test Cards (AST-P643 REF 418671), 20

cards/kit.

limitation related to EUCAST breakpoints for Teicolplanin.

via email on February 24, 16 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.

distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

70 US Recall 11/05/16

Biomerieux Inc 595


2320


P645 REF 419602), 20 cards/kit.




71 US Recall 12/05/16

Medtronic 6135

Gunbarrel Ave

Boulder CO 80301-3214

Battery Pack Used with the Capnostream"20 and

Capnostream"20p Patient Monitor, Battery Packs Model

Number - 016400, 010520. Battery Pack used with the

Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack

powers the monitor when AC power is not available or when monitoring is required during

intra-hospital transfer of patients. The Capnostream"20

and Capnostream"20p is a combined capnograph/pulse

oximeter monitor and its accessories are intended to

provide professionally trained health care providers with continuous, non-invasive

Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.

Medtronic sent an Urgent Medical Device Recall letter dated April 16, by postal mail or courier to all affected customers. The letter instructed users to remove and properly dispose of current batteries. If product was further distributed customers were instructed to forward the recall letter. Customers were asked to completed and return the Acknowledgement and Receipt Form by fax or email. Customers with questions should contact Technical Services at 800-635-5267, option 1, ten 1 and 1 or by email at [email protected]. For questions regarding this recall call 303-876-8859.

Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.

measurement and monitoring

of carbon dioxide concentration of the expired

and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional

oxygen saturation of arterial hemoglobin (SpO2) and pulse

rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-

type facilities, and intra-hospital transport

environments.

72 US Recall 13/05/16

Lumenis Ltd 13

Hayetzira St.,Yokneam Ind. Park Yokneam

Israel

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter

(KT-1014971).

Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.

Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.

73 US Recall 14/05/16


, Inc. 511

Benedict Ave

Tarrytown NY 10591-

5005

ADVIA Chemistry Triglyceride_2, concentrated;

TRIG_c; Catalog # SMN # 10697575.

For in vitro diagnostic use in the quantitative measurement

of triglycerides in human serum and plasma on ADVIA

Chemistry systems.

Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.

Siemens mailed an Urgent Field Safety Notice, dated March 16, to customers confirming the ADVIA Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. Siemens asked customers to discontinue use of and discard kits from the two referenced lots, complete and return the Field Correction Effectiveness Check attached to the letter within 30 days. Customers were to review their inventory to determine their laboratory 's replacement needs. Customers are asked to retain the letter for their records and forward a copy to anyone that received the product. Customers may contact Siemens Customers Service or their local technical support.

Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great

Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.

74 SA Recall 09/05/16

Medtronic Cardiovasc

ular Revasculari

zation & Surgical Therap

(Additional details are provided in

the attachment

)

Neurostimulator system for pain therapy

Description: Spinal cord electrical stimulation system,

analgesic

Medtronic has confirmed four (4) instances of loss of therapy during recharging of a RestoreSensor implantable neurostimulator, for a rate of 0.007% (4 / 54.516) of devices distributed worldwide. By design, stimulation therapy turns off when battery voltage depletes below 3.575 volts. In the reported occurrences, a charging session was terminated prior to obtaining a recharge threshold voltage of 3.615, which triggered a rapid battery depletion state. As a result of the rapid battery discharge state, the implanted neurostimulators depleted to 1.925 volts (a state of overdischarge) in one to two days rather than the typical 30 days. Insufficient coupling (Charging Efficiency) between the recharger and the implanted neurostimulator during the recharge session was found to be a key factor in the reported events. Note that once a device is in the over discharge state, therapy is interrupted with return of patient symptoms and can only be restored using the Physician Recharge Mode of the recharger. As described in labeling, if three occurrences of overdischarge occur, the neurostimulator will trigger end of life, and must be replaced to resume therapy.

Medtronic will deliver a FSN to affected Spinal Cord Stimulation implanting and managing physicians to make them aware of this potential issue and provide recommendations to mitigate the risk associated with this issue.

From attachment - AT BE BU CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK TR Switzerland and Turkey

75 SA Recall 11/05/16

Intuitive Surgical Inc (Additional details are provided in

the attachment

)

da Vinci Xi Universal Seal Surgical Endoscope Instrument

Control System

Intuitive Surgical identified particulate during quality inspections of the insufflation stopcock on the da Vinci Xi 5 mm-8 mm Universal Seal. The particulate has the potential to be introduced into the cannula lumen when insufflation is connected. Although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. During abdominopelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (HDPE) particulate, its small size and the benign particulate geometry.

Until this issue is resolved, as an alternative to insufflation through the da Vinci Xi 5 mm-8 mm Universal Seal (PN 470361) or the 12 mm & Stapler Universal Seal (PN 470380) during intracardiac procedures, use an angio-catheter, or Veress needle, through the chest wall for initial access and to maintain insufflation throughout the procedure. Do NOT use the da Vinci Xi 5 mm- 8 mm Universal Seal or the 12 mm & Stapler Universal Seal for insufflation, or open the stopcock during the procedure.


LIST

1 AUS Recall 16/05/16 Ortho-Clinical

Diagnostics

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro


The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using VITROS AFP Reagent Packs. Ortho Clinical Diagnostics (Ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. The investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. There have been no reports of injuries as a result of this issue.

Recall for Product Correction - Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives. Previously reported results are valid, providing that QC results were within acceptable limits.

2 AUS Recall 17/05/16 Covidien Pty Ltd

Laryngeal Tube Set – size 4 (LTS-D S4 Adult)

An issue has been identified where size 5 laryngeal tubes have been inadvertently packaged in size 4 Laryngeal Tube Set packs. The tubes within the pack are correctly labelled as size 5 and this information is

Recall - Users are asked to quarantine and discontinue use of the affected item code and lot listed in the customer letter and to follow the instructions given when returning the goods. If your facility has distributed the affected products to other persons or facilities, customers are also asked to

visible through the packaging. promptly forward a copy of the recall letter to those

recipients.

3 AUS Recall 18/05/16 Nipro

Australia Pty Ltd

TRUEresult Blood Glucose Test Strip (10 counts) (used with the

TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD)

This recall has been initiated as a limited number of sealed test strip vial boxes from the affected TRUEresult blood glucose test strip batch may include an open test strip vial. Test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. In particular, test strips exposed to the environment may provide falsely low blood glucose results. Falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.

Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return.

4 AUS Alert 18/05/16 Medtronic Australasia

Pty Ltd

RestoreSensor Implantable Neurostimulators

Medtronic has confirmed 4 instances of loss of therapy during the recharging of a RestoreSensor implantable neurostimulator, at a rate of 0.007% worldwide. By design, stimulation therapy turns off when the battery voltage depletes below 3.575 volts (< 0% battery level). Insufficient coupling (Charging Efficiency) between the recharger & the implant during the recharge session was found to be a key factor in the reported events which consequently led to the inadequate recharge of the battery & subsequent loss of stimulation therapy. If the insufficient recharge coupling is continued & the battery is not recharged to restart stimulation therapy, the battery can discharge to an over discharge (OD) state. Under normal use conditions, the patient has 30 days to recharge the device to avoid experiencing a battery OD state. In this scenario, this time period is reduced to 1–2 days. If three occurrences of OD occur, the

Hazard Alert - Medtronic advises patients to follow the current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger, specifically: - Check the neurostimulator battery charge level once a day or more frequently as needed. - Keep the neurostimulator sufficiently charged to maintain therapy. It can be charged at any time; users do not need to wait for a low battery message. - During neurostimulator recharging, monitor the Charging Efficiency row and adjust the antenna to obtain as many solid black boxes as possible. If only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger. - During recharging, ensure the neurostimulator Battery Charge Level is at least 25% before ending the charge session. However, a full battery charge is ideal. - Medtronic is working with the TGA to assess the best approach to resolve the reported issue

implant will trigger end of life, and must be replaced to restore therapy.


ConMed Linvatec Australia Pty Ltd

ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive

Electrodes

The ThermoGard Dual Dispersive Electrode Pads are not compatible with some brands of electrosurgical generators using “passive” CQM (Contact Quality Monitoring) Systems. Whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a “passive” CQM Electrosurgical Generator.

ConMed Linvatec is advising users to inspect stock and discontinue use of affected devices. Product can be returned to ConMed for credit.

6 AUS Alert 19/05/16 Zimmer Pty

Ltd Sterile-Packaged Knee Implants

An issue has been detected with the foil pouches of specific lots of sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. Retrospective testing performed by Zimmer Biomet as a result of an internal review of the packaging system revealed that in some instances, tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample. No product complaints have been reported for this issue. The affected product was distributed between April 2011 and March 16. In a worst case scenario, if an issue with the foil pouch is detected during surgery, this will result in a slight delay to obtain another implant. If there is an issue with the foil pouch that goes undetected and also has resulted in a loss of sterility, a peri-prosthetic infection may occur. The risk associated with a peri-prosthetic infection is a revision or potential multi-stage revision to treat the infection.

Hazard Alert - Peri-prosthetic infections associated with the device/surgical site are most likely to manifest within 12 months of the device being implanted. Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents.

7 AUS Recall 19/05/16 Stryker

Australia Pty Ltd

Specialty Size 33mm Reduced Diameter Reaming Cutter

Stryker has discovered that the Specialty 33mm Cutter outer diameter was designed too large and would thus prevent the device from passing through the Specialty Clamping Barrel. This may result in the surgery time being extended by up to 15 minutes to retrieve

Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker.

and use an alternative readily available instrument.

8 AUS Recall 19/05/16 Elekta Pty

Ltd Hexapod iGUIDE 2.1, iGUIDE

2.2

The manufacturer has identified a software issue which may lead to incorrect patient positioning during treatment. In a specific scenario the software may prompt the user several times to move the HexaPOD to its DRIVE (*START) position. If the user follows this request the HexaPOD will move to DRIVE (*START). In a consecutive step iGUIDE shows hints to move the couch top with the Precise Table back to the initial imaging position. However, this position is reached only with a coarse movement. The final fine adjustment move, executed by the HexaPOD, is missing. The coarsely reached imaging position becomes the new registered position for the actual Position Error Correction (PEC) movement to the target position. A theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement.

Electa advises users to avoid imaging in the PARK (*LOAD) position. If the user has performed imaging when the HexaPOD is not in the DRIVE (START*) position, cancel all move to DRIVE (START*) requests. Thus the HexaPOD remains in the imaging position. If the user then applies the PEC the HexaPOD will reach the target in the specified accuracy. The movement to the target will be a combination of Precise Table and HexaPOD moves. In case of any doubts perform a verification scan. A software update which will correct the behaviour of the affected iGUIDE versions 2.1 and 2.2 will be provided to the affected customers free of charge as soon as it becomes available.


Healthcare Pty Ltd

Dimension Vista Enzyme 2 Calibrator (used on the

Dimension Vista System). An in vitro diagnostic medical device

(IVD) Multiple Lot Numbers and

Expiry Dates affected

Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with certain Dimension Vista Enzyme 2 Calibrator lots. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. There is no risk to patients however there may be a delay in reporting patient results.

Recall for Product Correction - Siemens has reassigned the bottle values of all Enzyme 2 calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided. A review of previously generated results due to this issue is at the discretion of the laboratory.


Healthcare Pty Ltd

Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro

Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay

Recall for Product Correction - Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of

diagnostic medical device (IVD) is calibrated with the affected Dimension

Enzyme II calibrator lots. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. There is no risk to patients however there may be a delay in results.

approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided. A review of previously generated results due to this issue is at the discretion of the laboratory.

11 HC Recall 16/05/16

Medtronic Inc. 710

Medtronic Parkway NE

Minneapoli

s 55432


A.KINETRA NEUROSTIMULATOR PULSE

GENERATOR & ACCESSORY KIT B.ACTIVA PC INS - MULTI-

PROGRAM NEUROSTIMULATOR

C.ACTIVA PC INS - DBS EXTENSION KIT FOR DEEP

BRAIN STIMULATION D.ACTIVA RC MULTI-PROGRAM

RECHARGEABLE NEUROSTIMULATOR

E.ACTIVA RC NEUROSTIMULATOR - DBS EXTENSION KIT FOR DEEP

BRAIN STIMULATION F.LOW PROFILE

NEUROSTIMULATOR EXTENSION

G.SOLETRA QUADRIPOLAR MULTI-PROGRAMMABLE

NEUROSTIMULATOR H.ACTIVA SC -

NEUROSTIMULATOR

12 HC Recall 16/05/16

Beckman Coulter,

Inc. 250 S.

Kraemer Blvd. Brea

92821 California

A. ALT OSR6x07

Beckman Coulter has identified that there is a possibility that drug interference from administration of sulfasalazine to patients may generate false low results with the assay which is the subject of this recall.

UNITED STATES

13 HC Recall 17/05/16

ALERE MEDICAL CO., LTD.

357 MATSUHID

AI MATSUDO, CHIBA-KEN 270-2214

JAPAN

A. ALERE TESTPACK+PLUS STREP A WITH OBC

Affected devices contain swabs that are defective. The defective swab shafts are yellow in colour when normally white and can be easily broken if bent. In cases where the swab is broken during sample collection from the throat, a patient's throat may be injured and/or the swab may be swallowed.

14 HC Recall 17/05/16

Terumo Medical

Corporation

950 Elkton Blvd

Elkton 21921

Maryland UNITED STATES

A. Destination Peripheral Guiding Sheath

B. Destination Carotid Guiding Sheath

C. Destination Renal Guiding Sheath

Certain Pinnacle Destination guiding sheaths containing an expiration date on or before August 31, 2018, may fail to meet product specifications for insertion force of 40 grams (1.4 ounces). If a guiding sheath does not have sufficient lubricity, there may be increased resistance noted during the insertion of the device into the patient, especially if the patient has scar tissue or difficult anatomy.

15 HC Recall 17/05/16

Carefusion 22745 Savi

Ranch Parkway Yorba Linda


A. Avea Ventilator

Incorrectly installed F1 fuse on the AVEA Ventilator TCA Board may result in a failed/blown fuse, causing loss of power to the UIM

16 HC Recall 18/05/16

Elekta Business

Area Software Systems Impac

Medical Systems

Inc.

A. MONACO 5

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. This occurs when the port shape used to define or edit the MLC positions extends beyond or inside the actual jaw positions.

13723

Riverport Drive

Missouri UNITED STATES

17 HC Recall 19/05/16

CANADIAN HOSPITAL SPECIALTIE

S LTD. DOING

BUSINESS AS CHS 2760

BRIGHTON ROAD

OAKVILLE L6H 5T4 Ontario CANADA

A. MED-RX ANESTHESIA KIT

Omega Laboratories, the supplier of sodium chloride, identified an out-of-specification (OOS) stability result for the pH value at the 12 month testing interval at 25 degrees celsius. Found result is 7.6 (limit is 7.0). The product shelf life is 48 months and the lot is out-of-specification before expiry. MED-RX anesthesia kits contain this component.

18 HC Recall 19/05/16

Synthes USA LLC

1101 SYNTHES AVENUE

Monument 80132

Colorado UNITED STATES

A. FLEXIBLE SHAFT, MEDULLARYLot or serial

number

Device did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

19 US Recall 19/05/16

The Anspach

Effort, Inc. 4500

Riverside Dr

Palm Beach Gardens FL

33410-4235

ANSPACH, Rx only, Otologic Curved Micro (OCCM)

Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD

Product Usage: The Otologic Curved Micro

(OCCM) Attachment and burrs are intended for cutting and

shaping bone primarily in otology procedures such as

cochleostomies.

Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/16 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please

US Distribution in the states of KY and TX.

include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to [email protected]. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. ¿ Return the documents to The Anspach Effort by: ¿ Fax: (561) 627-2682 ¿ Scan/email: [email protected] ¿ Giving them to your DePuy Synthes Sales Consultant ¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.

20 US Recall 19/05/16

The Anspach

Effort, Inc. 4500

Riverside Dr

Palm Beach Gardens FL

33410-4235

ANSPACH, Rx only, Otologic Curved Micro (OCCM)

Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage:

The Otologic Curved Micro (OCCM) Attachment and burrs

are intended for cutting and shaping bone primarily in

otology procedures such as cochleostomies.

Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/16 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to RA-DPYUS-

US Distribution in the states of KY and TX.

[email protected]. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. ¿ Return the documents to The Anspach Effort by: ¿ Fax: (561) 627-2682 ¿ Scan/email: [email protected] ¿ Giving them to your DePuy Synthes Sales Consultant ¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.

21 US Recall 20/05/16

Ortho-Clinical

Diagnostics 100 Indigo Creek Dr

Rochester NY 14626-

5101

1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II

Reagent Pack (Unique Device Identifier No.

10758750002320, 20758750002327) and the

2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device

Identifier No. 10758750002337,

20758750002334); For quantitative measurement of

human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

Affected Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-16), Lot Number: 1440 (With Expiry Date 15-Aug-16,

Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-16)

and Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-16)

When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

On February 18, 16, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification letters and Confirmation of Receipt Forms to their customers (Ref. CL16-043) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to immediately discontinue using and discard all remaining inventory of the listed lots. Ortho Clinical Diagnostics will replace all remaining inventory or provide account credits as indicated on the confirmation of receipt form. Customers are advised to review previously reported results using the affected lots and to discuss these findings with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. Complete and return the Confirmation of Receipt form to Joe Falvo via email at [email protected] or by fax to 1-888-557-3759 or to 1-585-453-4110. Clients with questions can contact Customer Technical Services at 1-800-421-3311 at any time.


22 US Recall 20/05/16 Hummingbi

rd Med 20371 Lake

ABG-HM-1 Hummi Micro Draw Blood Transfer Device

Product Usage:

Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between

On 10/01/15 the firm sent out customer notification letters. The letter states for the following actions to be taken: 1. Customers using the Hummi Micro Draw device are

Distributed in the states of CA, KY, MD, GA,

Forest Dr

Ste A6 Lake Forest CA 92630-

8106

It is used for blood transfer and collection from Peripheral

Arterial Line Catheters. Lot 15180, 15286, 15287, 15300,

15305

the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.

recommended not to use the identified lot. 2. A local distributor/sales representative will be contacting customers to arrange a return of the identified lot for credit and arrangement of replacement. 3. Replacement product should be available within 10 days of 10/30/15. 4. During the period of product unavailability customers might want to choose to temporarily to return their previous method for blood drawing. The firm requests a Reply Form be completed and returned via fax at 949-583-2775 or email to [email protected]. On 11/19/2015 the firm sent out a second notification letter involving additional recall lots. The firm provided the same instructions to customers as their previous notification; however stated replacement product should be available by mid December 2015.

and IL.

23 US Recall 20/05/16

Angiodynamics Inc. (Navilyst Medical

Inc.) 10 Glens Falls Tech

Park Glens Falls NY 12801-

3864

AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-

187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit

and AngioVac Circuit Pack are designed to be used with the

AngioVac Cannula.

Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

On 3/21/16, AngioDynamics sent recall notification packages (dated 3/21/16) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/16) and return the Reply Verification Tracking Form, provided in the recall notification.


24 US Recall 20/05/16

Angiodynamics Inc. (Navilyst Medical

Inc.) 10 Glens Falls Tech

Park Glens Falls NY 12801-

3864

Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100,

STERILE, Rx Only, Single Use Only -- The AngioVac Circuit

and AngioVac Circuit Pack are designed to be used with the

AngioVac Cannula.

Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

On 3/21/16, AngioDynamics sent recall notification packages (dated 3/21/16) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/16) and return the Reply Verification Tracking Form, provided in the recall notification.


25 US Recall 20/05/16

B. Braun Medical,

Inc. 901

Marcon

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

The firm, B. Braun Medical Inc., sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 4/26/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate their current inventory for the affected lots; fill out

Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR,

Blvd

Allentown PA 18109-

9512

471734. Usage: Infusion of

solution/medication into implanted intravascular ports.

the Product Removal Acknowledgement form and record the total number of units found, and return the form to B. Braun Medical Inc. Quality Assurance department by faxing the form to 610-849-1197 or email to PA_Quality [email protected] within two weeks of receipt. A BBMI Customer Support Representative will contact the customer to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.

TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.

26 US Recall 20/05/16

Valeant Pharmacue

ticals Internation

al 400

Somerset Corporate

Blvd Bridgewater NJ 08807-

2867

Orapharma (Onpharma) Onset Mixing Pen Rx only,

Product/Part Number 1054-02. Manufactured for Onpharma

Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a

standard 3 mL size cartridge into a second fluid

container.Dosing Mechanism

It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. However, the current labeling and IFU does not stipulate this time period.

Valeant sent a letter entitled "Field Correction to Orapharma Onset Mixing Pen," dated 1/29/16, to customers via UPS. The letter identified the affected device and the issue involved. The firm recommends that users stop using the device if it had been in use for more than 18 months. Customers were to refer to the list of the affected lots to determine if their device needed to be replaced. If the device was one of the ones identified, users were to contact Valeant Pharmaceuticals to arrange for a replacement at no charge. Questions should be directed to customer service 800-321-4576.

Nationwide Distribution

27 US Recall 20/05/16

Leica Microsyste

ms, Inc. 1700 Leider

Ln Buffalo Grove IL 60089-6622

Novocastra Liquid Mouse Monoclonal Antibody

Calretinin, NCL-L-CALRET-566. Intended for the qualitative

identification by light microscopy of human

calretinin molecule in paraffin sections.

Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.

A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; [email protected]

Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.

28 SA Recall 19/05/16

Abbott (Additional details are provided in

the

CELL-DYN Emerald Cleaner .

Abbott has identified occurrences where the CELL-DYN Emerald analyzer generates Quality Control (QC) Out Of Range Low for parameters RBC and PLT.

If You HAVE an alternate Cleaner Reagent lot available in inventory (other than 6853, 6901, or 6953). Then Immediately discontinue use of impacted Cleaner lot(s) 1. Switch to the alternate lot of Cleaner Reagent. 2. Run the Decontamination Procedure per CELL-DYN Emerald

attachment

) Operator’s Manual (9140859 version H) page 9-16 steps 1 -3. (see attachment 1) This will take 15 – 30 minutes. 3. Check the QC and follow any additional laboratory procedures. Destroy any remaining inventory of impacted Cleaner lot(s) according to your laboratory procedures. If you do not have an alternate lot available, And are not experiencing QC Out Of Range Low for parameters RBC and PLT Immediately order a replacement Cleaner lot.

29 SA Recall 19/05/16

GE Healthcare (Additional details are provided in

the attachment

)

Revolution CT systems

GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm.

You can continue to use your Revolution CT product. Be sure to follow the Patient Positioning warning outlined in the Revolution CT User Manual.. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.


LIST

1 AUS Recall 23/05/16 Apotex Pty

Ltd Zoledasta (Zoledronic Acid

5mg/100mL) injection solution

This batch is being recalled due to the possibility that particulates may form in the solution on long term storage, which may also result in a reduction in the active ingredient quantity. This issue has occurred as a result of this particular batch being packaged in the incorrect glass vial. No safety or efficacy concerns have been reported for the affected batch, which is currently early in its shelf-life.

Recall - Apotex is instructing customers to inspect stock on hand and quarantine all affected units prior to return to the relevant wholesaler as per the instructions in the customer letter.


Healthcare Pty Ltd

Hettich Centrifuge Bucket Model 4464-R (used on

StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High

Throughput Centrifuges and FlexLab). An in vitro diagnostic

medical device (IVD)

Siemens Healthcare Diagnostics is issuing an Urgent Recall for Product Correction Notice for the Hettich centrifuge buckets (Model 4464-R) of affected Hettich Rotanta 46 RSC Robotic and Rotanta 460 Robotic Centrifuges. Hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. There is the possibility that material changes may have an impact of the strength of the buckets. When the Hettich Centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the

Recall for Product Correction - Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.

potential for movement/rotation of the Centrifuge.



Ltd

DuraDiagnost X-ray systems with software version 4.0.2,

4.0.3 and 4.0.4

A firmware anomaly inside the detector (PX4343RG) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. This may result in an inadequate acquisition of the X-ray image. If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.

Recall for Product Correction - Philips is providing a software upgrade to version 4.0.5 to permanently correct this issue.



Ltd

DuraDiagnost X-ray systems with software version 3.0.3

A firmware anomaly inside the detector (PX4343RG) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. This may result in an inadequate acquisition of the X-ray image. If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.

Recall for Product Correction - Philips is implementing a software upgrade to version 3.0.6 as a permanent correction.

5 AUS Alert 25/05/16 Zimmer Pty

Ltd Self Tapping Bone Screws, 6.5 x

20 and 6.5 x 25

Zimmer Inc. has become aware of specific lots of sterile Hip and Trauma Implant Screws manufactured between February 16 and March 16. These screws are packaged with a double barrier system, two plastic trays and two Tyvek lids, to provide sterile integrity. Process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray, which were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. The outer tray is not affected and the device’s sterile integrity remains until the outer tray is opened.

Azard Alert - Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. Patient follow up is at the discretion of the treating surgeon.

6 AUS-TGA

Recall 25/05/16


Ltd

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software version 4.1.3,

4.1.4 and 4.1.5

Philips Healthcare became aware of certain issues with the affected products through testing and customer feedback. The identified issues include; - IMR Cardiac - Irregular Appearance of


Contrast in Vessels; -Missing Image Annotation’s in CCT; - Halo Artefacts; - Unable to Match Z Locations on Prescan and 4D CT Scan; - Incorrect Z Annotation on Plan Box for Coronal/Sagittal Surviews; - Unintended Change of Acquisition Timing on Scan Ruler; - Bolus Tracker does not Trigger as Expected; - System Unresponsive when Paused; - System Becomes Unresponsive During Timed Scan; - Unplanned Results During Multi-Phase Pulmo Series, may Cause a System Crash; - Communication Errors Between Host Computer & Gantry; and - Pin Wheel Artefact Using 0.67mm Slice Width.

7 AUS Recall 25/05/16 Elekta Pty

Ltd Monaco software versions

5.10.00 and higher

When DICOM is exporting a 3D Monaco plan and the “Composite Field sequencing” (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined. This occurs when the port shape used to define or edit the MLC positions extends beyond or inside the actual jaw positions. The defect is triggered when using a workflow for Forward Planning IMRT that involves creating multiple beams for the same gantry angle with a single MLC shape defined for each beam. These beams are then exported using CFS to combine the individual 3D beams into a single IMRT beam sequence. The planned and approved dose distribution will not agree with the dose delivered. This deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the MLC shape is drawn outside or inside of the collimator jaws. There is a remote

Recall for Product Correction - Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction.

probability that serious injury could occur.

8 AUS Recall 25/05/16 CSL Limited 16 Fluvax, 10 x 0.5ml packs

A small proportion of the 16 Fluvax, 10 x 0.5ml packs for the private market, may have been released to the market without containing the required Prescribing Information (PI) leaflet. The PI states that this season’s vaccine is indicated for use only in persons aged 5 years and over. It must not be used in children under 5 years. It should only be used in children aged 5 to under 9 years based on a careful consideration of potential risks and benefits in the individual.

Recall for Product Correction - Seqirus is providing users with the required Product Information Leaflet. A review of patients aged between 5 and 9 years of age who may have received the vaccine is at the discretion of the healthcare professional.



Ltd

Philips Brilliance iCT/iCT SP with software version 4.1.3,

4.1.5

Philips Healthcare became aware of certain issues with the affected products through testing & customer feedback. The identified issues include; - IMR Cardiac - Irregular Appearance of Contrast in Vessels; - Missing Image Annotations in CCT - Halo Artefacts - Incorrect Z Annotation on Plan Box for Coronal/Sagittal Surviews - Post Injection Delay Between Timed Scans may be Inaccurate - Unintended Change of Acquisition Timing on Scan Ruler - Bolus Tracker does not Trigger as Expected - Cardiac Step & Shoot stops after Arrhythmia detected - Tracker Scan Halted with FDOM - Error when Auto ROI Placement Outside Patient Anatomy - No "GO" when HR outside acceptable range - Unplanned Results During Multi-Phase Pulmo Series, may Cause a System Crash - Dynamic Myocardial Perfusion Acquisition Halted After 1st Shot - Double Clicking ECG Phase Bar Crashes Exam Application - Incorrect Phase Tolerance for Cardiac S&S


& - Ring Artefacts on High Resolution Images, iDose4 & IMR


Roche Diagnostics

Australia Pty Limited

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical

device (IVD)

Investigations by Roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of ONLINE TDM Gentamicin with Preciset TDM I Calibrator. A combination with TDM control set lot 125783 does not show this effect. This may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.

Recall - Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS (except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems.

11 AUS Recall 27/05/16 Abacus ALS

Pty Ltd

EliA IgG Conjugate. An in vitro diagnostic medical device

(IVD).

Investigation of complaints received has concluded that when using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-CCP-signals can be elevated for the listed conjugate lots. The positive bias of the EliA CCP test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive. Testing on clinical samples of both confirmed Rheumatoid Arthritis (RA) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). The results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.

Recall - The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available.


Draeger Medical Australia Pty Ltd

Drager Ventstar Paediatric Circuit, used in conjunction

with the Dräger Oxylog 3000plus Transport Ventilator

During the course of routine internal testing Drager detected isolated leakages at the check valve (one way valve of the inspiration branch) of the above mentioned disposable paediatric ventilation circuit. Leakage at the check valve can result in a

Recall - Drager urgently recommends that users immediately inspect any stock and dispose of any product (part number 5704964) with a date of manufacture up to and including 03-16. A Free of charge replacement product can be obtained by following the instructions in the customer letter.

patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the exhaled gas with subsequent reduced oxygen concentration for the patient. This leakage is not detected during the ventilator operational readiness check. To date, Drager has not received any complaints associated with this issue. Further detailed investigations have shown that the check valve functions properly with no leak observed at positive end-expiratory pressures above 5 mbar I cmH20. The problem only occurs at PEEP values below 5 mbar I cmH20.

13 HC Recall 23/05/16

MEDIX I.C.S.A.

MARCOS SASTRE

1675 BUENOS AIRES, EL

TALAR B1618EWC

ARGENTINA

A. NATALCARE ST-LX

A batch of hinges which secure the oval ports to the incubator NatalCare ST-LX have a possible manufacturing problem. Some of the screws holding the hinge can become loose or the material of the hinge is broken easily and could cause a possible detachment of the oval ports.

14 HC Recall 23/05/16

HU-FRIEDY MFG. CO.,

LLC 3232 N.

ROCKWELL ST

Chicago 60618 Illinois

UNITED STATES

A. #3 Goldstein In Flexi-thin Composite Instrument

B. CIGFT3 Stainless Steel #3 Goldstein flexi thin composite

instrument #41 handle C. CIGFT36 Stainless Steel #3

Goldstein Flexi-Thin Composite Instrument, #6 handle

D. CIGFT38 Stainless Steel #3 Goldstein Flexi-Thin Composite

Instrument, #8 handle

The company recorded a higher rate of returns for this product for breakage compared to the historic average. The company analyzed the mode of failure and identified an opportunity to improve the manufacturing process for this item. The company wishes to replace product in the field to lessen the chance of customer dissatisfaction.

15 HC Recall 23/05/16

Steris Corporatio

n 2720

Gunter Park East

A. STERIS OT1000 SERIES ORTHOPEDIC SURGICAL

TABLES

The OT 1000 Series Orthopedic Surgical Tables are mobile, power operated orthopedic tables. They provide flexible, easy-to-use, articulated posturing of the patient for reconstructive and reparative orthopedic procedures. Steris has identified

Montgomery

36109 Alabama UNITED STATES

that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.

16 HC Recall 24/05/16


Products Gmbh

Emil-Von-Behring-Str.

76 Marburg

35041 GERMANY

A. DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT

Siemens Healthcare Diagnostics has confirmed that the Dimension Vista Flex HCYS reagent cartridge catalog # K7044, lot number 15243MA shows a reduced open well stability that does not meet the claimed time frame. As a consequence QC recoveries can be found below the assigned ranges, giving invalid runs that may prompt customers to a new calibration.

17 HC Recall 24/05/16

Hillrom Corporatio

n 1069 State

Route 46 East

Batesville 47006

UNITED STATES

A. VOLKER 2080 NURSING BEDS

Volker/Hill-Rom has received eight reports over the past 20 years alleging false latching of the side rails. One complaint resulted in injury. Through analysis it has been determined that a field corrective action should be initiated.

18 HC Recall 24/05/16

Siemens AG

Wittelsbacherplatz 2

Muenchen 80333

GERMANY

A. CIOS ALPHA

During manufacturing process, it was discovered that the crimp-connection of a cable was faulty. In case the cable gets loose, the high voltage circuit of the system is discharging extremely slowly after powering off the system. This error may not lead to any harm to patients or users. The risk remains only to service personnel and only if they do not follow the described procedures for servicing the high voltage circuits in the device.

19 HC Recall 25/05/16 Ortho

Clinical Diagnostics

A. VITROS Chemistry Products dTIBC Reagent

Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential for positively biased results generated when

Inc.

100 Indigo Creek Drive Rochester

14626 New York UNITED STATES

using VITROS dTIBC Reagent, Gen 30. Ortho determined that there are incorrect values (data/calibration mathematics) on assay data diskettes (add) for VITROS Calibrator Kit 29 that support VITROS dTIBC Reagent, Gen 30. The incorrect values will cause a positive bias in sample results (i.e., patient samples, proficiency fluids and quality control fluids).

20 HC Recall 25/05/16

JOHNSON &

JOHNSON INTERNATIONAL, C/O EUROPEAN LOGISTICS

CENTRE LEONARDO

DA VINCILAAN, 15, DIEGEM BELGIUM

A. PHYSIOMESH FLEXIBLE COMPOSITE MESH

Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. Recurrence / reoperation rates (respectively) after Laparoscopic Ventral Hernia Repair using ETHICON PHYSIOMESH Flexible Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.

21 HC Recall 25/05/16

Immucor Inc.

3130 Gateway

Drive, P.O. Box 5625 Norcross 30091-

5625 Georgia UNITED STATES

A. Capture-R Ready-ID

Immucor has received reports that plates of Capture-R Ready-Id (lot id 296) are being aborted due to "measurement out of range" errors after the strip clean read on the Galileo NEO instrument, due to cell 13 exhibiting a yellow color.

22 HC Recall 25/05/16


(Cleveland) Inc.

595 MINER ROAD

BRIGHTVIEW XCT IMAGING SYSTEM

B. SYST, BRIGHTVIEW X WITH CRYSTAL

During a Non-auto Body Contouring (abc), non-circular, REL-180 scan, the detector may come in contact with the patient. If this occurs, contact sensors would pause the scan.

CLEVELAND Ohio

UNITED STATES

23 HC Recall 26/05/16

Conmed Corporatio

n 525 French

Road Utica 13502


A. THERMOGUARD DISPERSIVE ELECTRODES

A version of the ConMed ThermoGard Dual Dispersive Electrodes, manufactured between October 1, 2014, and July 5, 2015, may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. A customer alerted ConMed of this condition on April 6, 16. These generators use a CQM (contact quality monitoring) technology which may rely on a preset upper limit (alarm limit) of the CQM impedance to detect pad lift. Please contact ConMed for a complete list of compatible CQM electrosurgical generators (esu's).

24 HC Recall 26/05/16

Edwards Lifesciences

LLC 1 Edwards

Way Irvine

UNITED STATES

A.EDWARDS EV1000 SYSTEM - MONITOR

B.EDWARDS EV1000 SYSTEM - DATA BOX

C.EDWARDS EV1000 SYSTEM - ETHERNET CABLE

D.EDWARDS EV1000 SYSTEM - BIFURCATED POWER SUPPLY

E.EDWARDS EV1000 SYSTEM - POWER ADAPTER

F.EDWARDS EV1000 SYSTEM - VOLUMEVIEW

THERMODIULTION CABLE G.EDWARDS EV1000 SYSTEM -

FLOTRAC CABLE

Edwards Lifesciences has initiated a voluntary safety alert regarding the EV1000A system to reinforce the proper set up of the external power supply according to the equipment's operator manual. The company received a recent event of an electrical fire, therefore is sending a notice to all customers with EV1000A systems installed to confirm installation against the current requirements documented in the operator's manual section EV1000 power adapter mounting bracket.

25 HC Recall 26/05/16

DEVICOR MEDICAL

PRODUCTS, INC.,

300 E-BUSINESS

WAY, FIFTH FLOOR

A. MAMMOTOME REVOLVE DUAL VACUUM ASSISTED

BIOPSY SYSTEM

It has come to the attention of Devicor Medical Products, Inc. That a MST1009 probe for the Mammotome revolve biopsy device in a stereotactic application may have been mislabeled. It is a 10 gauge device with a 9 cm needle. In lot number F11537107D1, a MST1009 was in a MST0815 package for a single unit. This

CINCINNATI 45241 Ohio

UNITED STATES

single unit was identified by a customer and returned.

26 HC Recall 26/05/16

Roche Diagnostics

GMBH


Mannheim 68305

GERMANY

A.VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO

B.VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR

ROCHE/HITAC

A reference standardization of the Roche vancomycin assays was done by the manufacturer against the reference method. It was decided to correct both methods against the reference method. The COBAS INTEGRA assay was corrected by a reagent modification. The instruction for use of the vancomycin assays already show a method comparison against COBAS INTEGRA with the changed formulation which is not yet available on the market. This may lead to the assumption that both methods are comparable and may affect the interpretation of results. Since the COBAS INTEGRA reagent is not yet adapted, results generated with COBAS INTEGRA are still up to 20% higher than with cobas c or modular p systems.

27 HC Recall 27/05/16

BEGO BREMER

GOLDSCHLAGEREI WILH.

HERBST GMBH & CO. KG,

WILHELM-HERBST-

STRASSE 1 BREMEN, BREMEN 28359

GERMANY

A. SEMADOS IMPLANTOLOGY SYSTEM - DOLDER ATTACHMENT/F

B. SEMADOS IMPLANTOLOGY SYSTEM - BALL ATTACHMENT

MINI C. SEMADOS IMPLANTOLOGY

SYSTEM - PRECI-CLIX FEMALE P

The CE Declaration of Conformity for products from the supplier ALPHADENT NV was declared invalid on April 4th, 16. The annulling of the CE Declaration of Conformity of ALPHADENT NV by the notified body Nemko is not linked to any safety problems associated with the medical devices. The annulling is the result of an application submitted by ALPHADENT NV on 13 September 2013 to the notified body to terminate its contract with the notified body. Nemko responded on 4 April 16 to this application and informed ALPHADENT NV about the annulling of the relevant CE Declaration of Conformity.

28 HC Recall 27/05/16 NORDICNEUROLAB AS

A. NORDICICE

Development team during the testing of new version (research) discovered a bug concerning handling of co-registration for

MOLLENDA

LSVEIEN 65C

BERGEN 5009

NORWAY

bold series. The bug was verified in the current version of 2.3.14

29 HC Recall 27/05/16


Inc. 511

Benedict Ave

Tarrytown 10591


A. ADVIA CENTAUR XPT INSTRUMENT

Siemens Healthcare Diagnostics has identified multiple issues with ADVIA Centaur XPT system software versions V1.0.1 Bbundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). These issues may affect the results generated by the system and are described below: 1. Sample tip error 2. Daily maintenance 3. Result reporting for high/low linearity samples 4. Auto-repeat conditions 5. Barcode misreads in rack id mode 6. Low probe wash 7. Las communication 8. System status unknown

30 HC Recall 27/05/16

Medtronic Navigation

Inc. 826 Coal

Creek Circle Colorado UNITED STATES

A. VISUALASE COOLED CATHETER LASER APPLICATOR

Manufacturer received reports of melting of the VCLAS catheters during procedures to ablate tissue. Manufacturer revised the recommended treatment parameters and revised and added warnings accordingly.

31 US Recall 23/05/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West

Chester PA

3.2 mm Three-fluted drill bit, sterile, Catalog ID #

03.010.060S Product Usage: Usage:

The 3.2 mm Three-fluted Drill Bits are instruments that can

be used with the following systems: Expert Lateral

Femoral Nail (part number

The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

DePuy Synthes sent an Urgent Notice Medical Device Letter dated April 19, 16 to customers. The identified the affected product, problem and actions to be taken. The letter instructed customers to examine their inventory to determine if they currently have the affected product. Customers were asked to complete and return the Verification Section of the recall notification letter. For questions call 610-719-5450.

US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO,

19380-5986

03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing,

Multiloc Humeral Nailing System, Suprapatellar

Instrumentation for Expert Tibial Nail, and Adolescent

Lateral Femoral Nails (ALFN).

MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

32 US Recall 23/05/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West

Chester PA 19380-5986

3.2 mm three-fluted Radiolucent Drill Bit/Needle

Point/145 mm Sterile Product Usage:

The 3.2 mm Three-fluted Drill Bits are instruments that can

be used with the following systems: Expert Lateral

Femoral Nail (part number 03.010.060S only), Expert Tibial

Nail, Expert Humeral Nailing, Multiloc Humeral Nailing

System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent

Lateral Femoral Nails (ALFN).

The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

DePuy Synthes sent an Urgent Notice Medical Device Letter dated April 19, 16 to customers. The identified the affected product, problem and actions to be taken. The letter instructed customers to examine their inventory to determine if they currently have the affected product. Customers were asked to complete and return the Verification Section of the recall notification letter. For questions call 610-719-5450.

US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

33 US Recall 23/05/16

GE Medical Systems,

LLC 3000 N

Grandview Blvd

Waukesha WI 53188-

1615

GE Healthcare, Discovery IGS 740. Indicated for use in

generating fluoroscopic and rotational images of human

anatomy.

Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

Consignees were sent on 4/15/16 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 16. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY,

IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.

34 US Recall 23/05/16

Elekta, Inc. 400

Perimeter Center Ter NE Ste 50

Atlanta GA 30346-1227

iGUIDE System, for patient positioning, with assistance of

a 30 Tracking System in a radiotherapy environment.

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 16. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.

IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

35 US Recall 23/05/16


1810 W Drake Dr

Tempe AZ 85283-4327

Reprocessed Daig Supreme Fixed Curve Diagnostic

Electrophysiology Catheters; Model #: 401450, 401877.

Indicated for temporary intracardiac sensing, recording,

stimulation, and electrophysiology mapping of

cardiac structures.

Mislabeled for size

The firm sent out customer notification letters on 04/28/16. Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed. Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found. Please return the completed and signed Recall Effectiveness Check Form to your local Stryker Sustainability Sales Representative or email to [email protected] or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality

Distributed in the state of NY and the country of Canada.

problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 - http://www.stryker.com/productexperience/ - The FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. On 05/12/16 the firm sent out a clarification letter to emphasize that use of affected lots of product should be discontinued. In addition, SSS would like to note that, use of devices larger than expected may result in excess force applied to the blood vessel. The risk to the patient can vary from a prolongation in procedure time, vessel rupture, organ damage or other unforeseen consequences. Some of these injuries may require surgery or other procedures to remedy. Any questions contact the Stryker Sustainability Solutions Sales Representative or Regulatory Affairs.

36 US Recall 23/05/16

GE Medical Systems,

LLC 3000 N

Grandview Blvd

Waukesha WI 53188-

1615

GE Healthcare, Discovery IGS 730. Indicated for use in

generating fluoroscopic and rotational images of human

anatomy.

Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

Consignees were sent on 4/15/16 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 16. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE,

UNITED ARAB EMIRATES, and UNITED KINGDOM.

37 US Recall 25/05/16

Accriva Diagnostics

Inc., dba ITC, dba

Accumetrics

6260 Sequence

Dr San Diego CA 92121-

4358

Accriva- APTT Cuvette for use on the Hemochron Jr. test

system

Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 16, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: [email protected]

U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.

38 US Recall 25/05/16

Limacorporate S.p.A

Via Nazionale

52 San Daniele

Del Friuli Italy

SMR glenosphere impactor/extractor; Used to

implant the glenosphere in the SMR Reverse Shoulder

replacement.

Complaints of intra-operative breakage of the glenosphere impactors/extractors.

The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA.

Distributed US (nationwide) and in Australia.

39 US Recall 25/05/16

Volcano Corporatio

n 2870

Kilgore Rd

Volcano s5, s5i, CORE and CORE Mobile systems with

software version 3.4 and v3.4 software kits.

Cardiology: The Volcano

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the

The firm, Philips, sent an "URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated 4/25/16 to its customers beginning April 29, 16 which include a technical service bulletin to explain how to assure the incompatibility issue does not affect system performance. The customers were

Worldwide Distribution: US (nationwide) and countries of: Japan, South

Rancho

Cordova CA 95670-6133

Universal (Core /Core Mobile), S5iz Platform Imaging System is

used for the qualitative and quantitative evaluation of

vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

hospital network and be forced to reboot instructed to do the following: -If you have an Impacted System but it is not connected to a network, this issue does not affect your system. Additionally, if network scans are not performed, this issue does not affect your system. -If you have an Impacted System that is connected to a network and staff performs network scans while the Impacted System is in operation, this issue does affect you and the circumstances exist for a manual reboot to occur during an active procedure. To avoid this, the following corrections must promptly be taken: 1. Disconnect your Impacted Systems from the facilities network. If you need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; OR 2. Do not permit your staff to perform network scans while the Impacted Systems are in operation. -Please complete, sign, and return the attached form indicating that you received this Field Corrective Action notification via Fax to Volcano Customer Service at (916) 638-8812 or email to [email protected]. If you have any questions, please call (800) 228-4728, option 5.

Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus,

Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea, Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,

40 US Recall 25/05/16

Biomet, Inc.

56 E Bell Dr Warsaw IN

46582-6989

PerFuse Decompression Instrument PN: 800-0541,

Lot:100650. Designed to access the femoral head for

decompression.

The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

Zimmer Biomet has initiated a voluntary recall of the PerFuse Decompression Instrument, following an investigation which identified that the Trocar and Plunger Assemblies are missing from the instrument. The firm contacted customers via telephone and e-mail on March 28, 16; and official recall notices were mailed via FedEx on 4/11/16. Customers were instructed to quarantine recalled items, Complete the Certificate of Acknowledgment and email a copy to [email protected]; Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or Call (800)FDA-1088 . Questions related to this recall should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.

41 US Recall 25/05/16

Draeger Medical,

Inc. 3135

Quarry Rd Telford PA

Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter

Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000).

Anesthesia Vaporizer

Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended.

Drager mailed a "Medical Device Safety Alert" dated April 21, 16, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.

US nationwide distribution, including Puerto Rico and Guam.

18969-1042

Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.

42 US Recall 25/05/16

RAYSEARCH LABORATO

RIES AB Sveavaegen

9 Stockholm

Sweden

RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment

planning and analysis of radiation therapy.

A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.

On February 10, 16, RaySearch Laboratories distributed Field Safety, Medical Device Correction notices and Reply Forms to their customers via email. To determine if the software version you are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported. This bug does not affect dose computations. Dose is always computed based on the stored system state. Actions to be taken by the user include the following: Always release the left mouse button before using other keys or mouse buttons, If the warning message "Temporary items should not be visible on approval" is displayed or if there is some suspicion that the bug may have triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. All customers should educate planning staff and all users about this workaround. All customers are advised to inspect product and identify all installed units with the referenced software version number, then confirm that you have read and understood the notice by completing and returning the reply form. The completed reply form should be returned to Freddie Cardel, [email protected], fax 888-501-7195. Customers with questions can call 1-877-778-3849, available east coast business hours all US working days.

**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom

43 US Recall 26/05/16

Biomet, Inc.


46582-6989

Various trauma and sports medicine instruments and

implants. guide, surgical, instrument

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 16, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa

Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

44 US Recall 26/05/16

Biomet, Inc.


46582-6989


implants. Fastener, fixation,

nondegradable, soft tissue.



Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

45 US Recall 26/05/16

Biomet, Inc.


46582-6989


implants. Fastener, fixation,

nondegradable, soft tissue.




46 US Recall 26/05/16

Biomet, Inc.


46582-6989


implants. Orthopedic manual surgical

instrument.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 16, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and

Worldwide Distribution - US (Nationwide) and globally to Argentina,

lead to an infection. instructions for responding to the formal recall notification.

Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

47 US Recall 26/05/16

Biomet, Inc.


46582-6989


implants. Spinal interlaminal fixation

orthosis.




48 US Recall 32605/16

Biomet, Inc.


46582-6989


implants. Appliance, fixation,

nail/blade/plate combination, multiple component.




49 US Recall 26/05/16 Biomet,

Inc. 56 E Bell Dr


implants.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 16, to all affected customers. Customers were instructed to locate and return the affected product, and

Worldwide Distribution - US

Warsaw IN

46582-6990

Passer. compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

(Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

50 US Recall 26/05/16

Biomet, Inc.


46582-6991


implants. Screw, fixation, bone.




51 US Recall 26/05/16

Biomet, Inc.


46582-6992


implants. Pin, fixation, smooth.




52 US Recall 26/05/16

Biomet, Inc.


46582-6993


implants. Bit, drill.




53 US Recall 26/05/16

Biomet, Inc.


46582-6994


implants. Reamer.




54 US Recall 26/05/16

Biomet, Inc.


46582-6995


implants. Rod, fixation, intramedullary

and accessories.



Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands,

Japan, Korea, Malaysia, Mexico, Peru.

55 US Recall 26/05/16

Biomet, Inc.


46582-6996


implants. Arthroscope.




56 US Recall 26/05/16

Biomet, Inc.


46582-6997


implants. Plate, fixation, bone.




57 US Recall 26/05/16

Biomet, Inc.


46582-6998


implants. cannula, surgical, general &

plastic surgery and accessories



Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa

Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

58 US Recall 26/05/16

Roche Molecular Systems,

Inc. 1080 US Highway

202 S Branchburg NJ 08876-

3733

An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2

Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the

cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).

An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).

Roche Molecular Diagnostics Inc. issued an Urgent Field Safety Notice dated March 15, 16 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Actions to be taken by the customer: " If you have utilized 2 ¿L of DNA PBB during testing of plasma specimens, the samples must be retested using the correct volume (2mL DNA PBB). Communication of this Field Safety Corrective Action This notice must be passed on to all those who need to be aware within your organization or to any organization/individual where the potentially affected devices have been distributed/supplied. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency. For questions regarding this recall call 908-253-7200.

Hungary

59 US Recall 26/05/16

RTI Surgical, Inc. (dba Pioneer Surgical

Technology, Inc.)

375 River Park Cir

Marquette MI 49855-

1781

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque

Sleeve. Spinal fixation device instrument.

Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.

RTI sent an Urgent Voluntary Product Notification dated April 22, 16, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (906) 226-4489.

US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.

60 US Recall 26/05/16

American Surgical

Company 45

Congress St Salem MA

01970-5579

American Surgical Delicot-J 15 mm x 20 mm

Ref Number: 63-04J (Japan Only) Product Usage:

Neurosurgical and Nonneurosurgical Sponges

Product packaging defective compromising sterility

American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France,

pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

61 US Recall 26/05/16

American Surgical

Company 45


01970-5580

American Surgical Delicot 4 mm x 50 mm

Ref Number: 63-05 Product Usage:



American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

62 US Recall 26/05/16

American Surgical

Company 45

American Surgical Delicot non-xray 10 mm x 13 mm

Ref Number: 63-03 non-xray


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address

Worldwide Distribution - US Nationwide and the


01970-5581

Product Usage: Neurosurgical and

Nonneurosurgical Sponges

affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

63 US Recall 26/05/16

American Surgical

Company 45


01970-5582

American Surgical Delicot 10

mm x 13 mm Ref Number: 63-03






64 US Recall 26/05/16

American Surgical

Company 45


01970-5583


Ref Number: 63-02 non-xray Product Usage:





65 US Recall 26/05/16

American Surgical

Company 45


01970-5584






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain,

Sweden, Switzerland, and United Kingdom.

66 US Recall 26/05/16

American Surgical

Company 45


01970-5585


Ref Number: 63-01J (Japan Only)






67 US Recall 26/05/16

American Surgical

Company 45


01970-5586


Ref Number: 63-01 Non X-Ray Product Usage:



American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands,

Option 2, Fax: 781-595-5460 Email: [email protected]

New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

68 US Recall 26/05/16

American Surgical

Company 45


01970-5587







69 US Recall 26/05/16

American Surgical

Company 45


01970-5588

American Surgical Ray-Cot 1/2" x 2"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong

contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

70 US Recall 26/05/16

American Surgical

Company 45


01970-5589

American Surgical Ray-Cot 1.5" x 3"






71 US Recall 26/05/16

American Surgical

Company 45


01970-

American Surgical Ray-Cot 3" x 3"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium,

5590 IFU, patties should not be used if in an open or damaged


Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

72 US Recall 26/05/16

American Surgical

Company 45


01970-5591







73 US Recall 26/05/16 American Surgical

Company


Ref Number: 60-12


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to

Worldwide Distribution - US Nationwide

45


01970-5592



be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

74 US Recall 26/05/16

American Surgical

Company 45


01970-5593






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United

Kingdom.

75 US Recall 26/05/16

American Surgical

Company 45


01970-5594

American Surgical Ray-Cot 1/2" x 1.5"






76 US Recall 26/05/16

American Surgical

Company 45


01970-5595






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South

Africa, Spain, Sweden, Switzerland, and United Kingdom.

77 US Recall 26/05/16

American Surgical

Company 45


01970-5596

American Surgical Ray-Cot 1/2" x 1/2"






78 US Recall 26/05/16

6

American Surgical

Company 45


01970-5597





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan,

described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

79 US Recall 26/05/16

American Surgical

Company 45


01970-5598

American Surgical Ray-Cot 1/4" x 1/4"






80 US Recall 26/05/16

American Surgical

Company 45


01970-5599

American Surgical Tonsil Sponges 1" Large




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong

are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

81 US Recall 26/05/16

American Surgical

Company 45


01970-5600

American Surgical Cotton Balls-Non-Strung 1/8"






82 US Recall 26/05/16

American Surgical

Company 45


American Surgical Cotton Balls-Non-Strung 1"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should

Worldwide Distribution - US Nationwide and the countries of Australia,

01970-5601

perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

83 US Recall 26/05/16

American Surgical

Company 45


01970-5602

American Surgical Cotton Balls-Non-Strung 3/4"






84 US Recall 26/05/16 American Surgical

American Surgical Cotton Balls-Strung 1/8"


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The

Worldwide Distribution -

Company

45 Congress St Salem MA

01970-5603



letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

85 US Recall 26/05/16

American Surgical

Company 45


01970-5604

American Surgical Cotton Balls-Strung 1.25"





Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland,

and United Kingdom.

86 US Recall 26/05/16

American Surgical

Company 45


01970-5605

American Surgical Cotton Balls-Strung 1"






87 US Recall 26/05/16

American Surgical

Company 45


01970-5606






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi

Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

88 US Recall 26/05/16

American Surgical

Company 45


01970-5607







89 US Recall 26/05/16

American Surgical

Company 45


01970-5608





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy,

by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

90 US Recall 26/05/16

American Surgical

Company 45


01970-5609







91 US Recall 26/05/16

American Surgical

Company 45


01970-5610

American Surgical Ultracot 70 mm x 10090 mm




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany,

to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

92 US Recall 26/05/16

American Surgical

Company 45


01970-5611

American Surgical Ultracot 30 mm x 90 mm (Glassine)

Ref Number: 23-15G Product Usage:





93 US Recall 26/05/16

American Surgical

Company 45

Congress St



Neurosurgical and


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this

Worldwide Distribution - US Nationwide and the countries of

Salem MA

01970-5612

Nonneurosurgical Sponges by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

94 US Recall 26/05/16

American Surgical

Company 45


01970-5613







95 US Recall 26/05/16 American American Surgical Ultracot 30 Product packaging defective compromising American Surgical issued an Urgent Recall and Field Safety Worldwide

Surgical

Company 45


01970-5614

mm x 70 mm Ref Number: 23-10



sterility Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

96 US Recall 26/05/16

American Surgical

Company 45


01970-5615






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden,

Switzerland, and United Kingdom.

97 US Recall 26/05/16

American Surgical

Company 45


01970-5616







98 US Recall 26/05/16

American Surgical

Company 45


01970-5617





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email:

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand,

[email protected] Portugal, Saudi


99 US Recall 26/05/16

American Surgical

Company 45


01970-5618







100

US Recall 26/05/16

American Surgical

Company 45


01970-5619





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel,

replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

101

US Recall 26/05/16

American Surgical

Company 45


01970-5620







102

US Recall 26/05/16

American Surgical

Company 45


01970-5621









103

US Recall 26/05/16

American Surgical

Company 45


01970-5622







104

US Recall 26/05/16

American Surgical

Company 45







01970-5623




105

US Recall 26/05/16

American Surgical

Company 45


01970-5624







106

US Recall 26/05/16

American Surgical

Company 45


01970-5625

American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G






107

US Recall 26/05/16

American Surgical

Company 45


01970-5626








108

US Recall 26/05/16

American Surgical

Company 45


01970-5627

American Surgical Americot Blue 1/2" x 2"

Ref Number: 20-32S Product Usage:





109

US Recall 26/05/16

American Surgical

Company 45


01970-5628

American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands,

Option 2, Fax: 781-595-5460 Email: [email protected]

New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

110

US Recall 26/05/16

American Surgical

Company 45


01970-5629

American Surgical Americot Blue 1/4" x 1.5"






111

US Recall 26/05/16

American Surgical

Company 45


01970-5630





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong

contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

112

US Recall 26/05/16

American Surgical

Company 45


01970-5631

American Surgical Americot Blue 3/8" x 3/8"






113

US Recall 26/05/16

American Surgical

Company 45


01970-





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium,

5632 IFU, patties should not be used if in an open or damaged


Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

114

US Recall 26/05/16

American Surgical

Company 45


01970-5633







115

US Recall 26/05/16 American Surgical

Company

American Surgical Americot Blue 1" x 3"

Ref Number: 20-10S


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to


45


01970-5634



be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

116

US Recall 27/06/16

American Surgical

Company 45


01970-5635






Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United

Kingdom.

117

US Recall 26/05/16

American Surgical

Company 45


01970-5636

American Surgical Americot Blue 1/2" x 1.5"






118

US Recall 26/05/16

American Surgical

Company 45


01970-5637








Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South

Africa, Spain, Sweden, Switzerland, and United Kingdom.

119

US Recall 26/05/16

American Surgical

Company 45


01970-5638







120

US Recall 26/05/16

American Surgical

Company 45


01970-5639





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan,

described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

121

US Recall 26/05/16

American Surgical

Company 45


01970-5640

American Surgical Delicot 30mm x 70mm

Ref: 63-10 Product Usage:





122

US Recall 26/05/16

American Surgical

Company 45


01970-5641

American Surgical Delicot 15mm x 20mm

Ref: 63-04 Product Usage:



American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong

are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

123

US Recall 26/05/16

American Surgical

Company 45


01970-5642

Mass Eye & Ear Finger Cot Nasal 2's






124

US Recall 26/05/16

American Surgical

Company 45


American Surgical Policot 1/2" x 2"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should

Worldwide Distribution - US Nationwide and the countries of Australia,

01970-5643

perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

125

US Recall 26/05/16

American Surgical

Company 45


01970-5644

American Surgical Policot 1/2" x 1.5"






126

US Recall 26/05/16 American Surgical

American Surgical Policot 1/2" x 1/2"


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The

Worldwide Distribution -

Company

45 Congress St Salem MA

01970-5645



letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

127

US Recall 26/05/16

American Surgical

Company 45


01970-5646

American Surgical Policot 1/4" x 1/4"





Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland,

and United Kingdom.

128

US Recall 26/05/16

American Surgical

Company 45


01970-5647

American Surgical Telfa 1" x 3" Ref Number: 80-13






129

US Recall 26/05/16

American Surgical

Company 45


01970-5648

American Surgical Telfa 1" x 1" Ref Number: 80-12





Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi


130

US Recall 26/05/16

American Surgical

Company 45


01970-5649

American Surgical Telfa 3/4" x 3"






131

US Recall 26/05/16

American Surgical

Company 45


01970-5650





American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy,

by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

132

US Recall 26/05/16

American Surgical

Company 45


01970-5651

American Surgical Telfa 1/2" x 1.5"






133

US Recall 26/05/16

American Surgical

Company 45


01970-5652

American Surgical Telfa 1/2" x 1/2"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany,

to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

134

US Recall 26/05/16

American Surgical

Company 45


01970-5653







135

US Recall 26/05/16

American Surgical

Company 45

Congress St

American Surgical Cylindrical Sponges-Strung 1/2" x 1.5"


Neurosurgical and


American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this

Worldwide Distribution - US Nationwide and the countries of

Salem MA

01970-5654

Nonneurosurgical Sponges by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

136

US Recall 26/05/16

American Surgical

Company 45


01970-5655

American Surgical Uniqcot 1/2" x 2"






13 US Recall 26/05/16 American American Surgical Uniqcot 1/2" Product packaging defective compromising American Surgical issued an Urgent Recall and Field Safety Worldwide

7 Surgical

Company 45


01970-5656

x 3" Ref Number: 67-09



sterility Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

138

US Recall 26/05/16

American Surgical

Company 45


01970-5657

American Surgical Uniqcot 1/2" x 1.5"





Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden,

Switzerland, and United Kingdom.

139

US Recall 26/05/16

American Surgical

Company 45


01970-5658

American Surgical Uniqcot 1/2" x 1/2"






140

US Recall 26/05/16

American Surgical

Company 45


01970-5659

American Surgical Uniqcot 1/4" x 1/4"




American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email:

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand,

[email protected] Portugal, Saudi


141

US Recall 26/05/16

American Surgical

Company 45


01970-5660

American Surgical Delicot X 9 mm x 50 mm

Ref Number: 63x07 Product Usage:





142

US Recall 26/05/16

American Surgical

Company 45


01970-5661

American Surgical Delicot X 6 mm x 50 mm

Ref Number: 63x06 Product Usage:



American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and

Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel,

replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]

Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

143

US Recall 26/05/16

American Surgical

Company 45


01970-5662


Ref Number: 63-10J (Japan Only)






144

US Recall 26/06/16

American Surgical

Company 45


01970-5663









145

US Recall 26/05/16

American Surgical

Company 45


01970-5664







146

US Recall 26/05/16

American Surgical

Company 45


Ref Number: 63-08J (Japan only)





01970-5665





147

US Recall 26/05/16

American Surgical

Company 45


01970-5666







148

US Recall 26/05/16

American Surgical

Company 45


01970-5667







149

US Recall 26/05/16

American Surgical

Company 45


01970-5668








150

US Recall 26/05/16

American Surgical

Company 45


01970-5669







151

US Recall 27/05/16

Smiths Medical ASD, Inc.

1265 Grey Fox Rd

Saint Paul MN 55112-

6929

CADD Administration Sets with Flow Stop, Product Reorder

No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-

7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-

7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-

7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24.

The CADD Medication Cassette Reservoirs with Flow Stop are a

modification to the current

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

Smiths Medical sent an "Urgent Medical Device Field Correction Action" letter dated April 20, 16. The letter was addressed to "Clinicians who oversee the use of the CADD¿ Administration Sets with Flow Stop and Distributors thereof". The letter described the Affected devices, Reason for Field Correction Action, Risk to Health, and Instructions to Customers (Distributors and Clinicians). Requested consignees to complete and return the "Field Corrective Action Confirmation Form". For questions regarding this notification, contact Smiths Medical Customer Service Department at 1-866-831-8399.

US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK,

CADD Medication Cassette

Reservoirs. The reservoirs will incorporate a set-based free flow protection component

(i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally

placed onto the pump incorrectly or become

detached from the pump. The Flow Stop will be located on

the reservoir housing, which is attached to the pump. The

reservoir will be provided to the user in an open state.

Before the reservoir can be attached to the pump, the blue

"CLIP" must be removed to activate the Flow Stop.

However, after attaching the reservoir to the pump, the user can still remove the reservoir

from the pump and prime it by holding the Flow Stop in the

open position.

SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.

152

US Recall 27/05/16

Pentax Medical

Company 3 Paragon

Dr Montvale NJ 07645-

1782

Video Duodenoscope Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

Pentax Inc. issued an "Urgent Field Correction" Letter dated February 19, 16, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provides information regarding the updated Reprocessing instruction for use along with some main changes in the Operation IFU. Instructions are also provided regarding prior versions of the Reprocessing and Operation Instructions for Use. A web posting went live on 2/19/16. For further questions, please call: Tel:800-431-5880 ext. 2064 (8:30AM- 5:00 PM, Monday-Friday, EST)

Nationwide

153

US Recall 27/05/16

Intuitive Surgical,

Inc. 1266 Kifer

Rd Bldg 100 Sunnyvale CA 94086-

SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model

numbers: 470361-03, 470361-04, 470361-05, 470361-06;

Part number: 470361. The da Vinci Xi Surgical System

cannula sterile single use

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

Upon discovery of the issue, Intuitive sent Urgent Product Safety Notices to all customers by e-mail to initially alert them of the situation. This will be followed by a formal letter that is scheduled to arrive on May 23, 16. Both notification request that users Do NOT use the da Vinci Xi 5 mm 8 mm Universal Cannula Seal or the da Vinci Xi 12 mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock

Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic,

5304 disposable cap for each

cannula . When attached to the cannula, the seal maintains insufflation when the cannula

is empty and when the instrument is inserted in the

patient during a surgical procedure.

during intra cardiac procedures. Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

154

US Recall 27/05/16

Intuitive Surgical,

Inc. 1266 Kifer

Rd Bldg 100 Sunnyvale CA 94086-

5304

SEAL,IS4000 PORTS,12MM&STAPLER,BOX

of 10; Model numbers: 470380-04, 470380-05,

470380-06; Part number:470380. The da Vinci

Xi Surgical System cannula seal is used with the cannula

accessory and provides sterile disposable cap for each

cannula. When attached to the cannula, the seal maintains

insufflation when the cannula is empty and when the

instrument is inserted during a surgical procedure.

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

Upon discovery of the issue, Intuitive sent Urgent Product Safety Notices to all customers by e-mail to initially alert them of the situation. This will be followed by a formal letter that is scheduled to arrive on May 23, 16. Both notification request that users Do NOT use the da Vinci Xi 5 mm 8 mm Universal Cannula Seal or the da Vinci Xi 12 mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during intra cardiac procedures.

Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea,

Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

155

US Recall 27/05/16

MicroAire Surgical

Instruments, LLC

3590 Grand Forks Blvd

Charlottesville VA 22911-9006

Pneumatic Impactor, General Surgery, With Microaire Hose

Connector Professional Use, Medical

Industry 2500-100

MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.

MicroAire sent an Urgent Medical Device Recall letter dated March 28, 16, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you please respond to this letter promptly to determine how many of these units you have and will be returning to MicroAire. Upon return of the instrument to MicroAire, MicroAire will provide you with replacements. Please complete and send back to MicroAire page two of this letter, indicating that you do have this instrument at your facility and whether you will be returning the instrument for replacement. You can email the form to MicroAire Customer Service at [email protected] or fax the form to 1-800-648-4309. You can contact MicroAire Customer Service at 1-800-722-0822 in the United States or 1-434-975-8000 outside the United States, between the hours of 8:30 AM and 5:30 PM (ET) Monday through Friday if you have any questions.

United States

156

SA Recall 23/05/16 Medtronic Advanced

Energy, LLC

Medtronic’s Deep Brain Stimulation

(DBS) labeling, in connection with Activa® PC, Activa® SC, Activa® RC and Activa® PC+S

Devices

Medtronic has become aware of a reported event of inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer. The patient had experienced an excellent result from DBS therapy in the management of Parkinson’s disease symptoms, and did not show evidence of the specific motor coordination symptoms identified in DBS labeling.

Be aware that loss of coordination may be a side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood.

157

SA Recall 23/05/16 Medtronic Advanced

Energy, LLC Deep Brain Stimulation

Medtronic’s post marketing surveillance for DBS therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current DBS labeling. The following events are associated with the DBS implant and tunneling the extension from the lead to the INS: • Cases of spinal accessory nerve injury • Severe bleeding or vascular injury

During the DBS implant, use caution while tunneling the extension from the lead to the INS to avoid tunneling too deeply or superficially because serious injury may occur.

• An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision • Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed


LIST

1 AUS-TGA

Recall 30/05/16

Johnson & Johnson

Medical Pty Ltd

Ethicon Physiomesh Flexible Composite Mesh

Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a medical device recall, in line with an Ethicon initiated worldwide medical device removal, of Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). The product is being removed following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using Ethicon Physiomesh Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.

Recall - Johnson & Johnson Medical advises customers to inspect stocks and immediately quarantine any affected units prior to their return. The management of patients who have been treated using ETHICON PHYSIOMESH Composite Mesh will remain at the discretion of the treating health care practitioner. A Hazard alert letter will be sent to Surgeons.


Healthcare Pty Ltd

ADVIA Centaur XPT SystemSiemens Material

Number: 10711433 All the ADVIA Centaur XPT system software versions

V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806),

V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle

1.1.243 SMN 11221979)

Siemens Healthcare Diagnostics has identified issues with all the ADVIA Centaur XPT system software versions that may affect the results generated by the system as described below: 1. There is potential for discrepant QC and patient results. Stop running the system until it is serviced if the conditions occur. The probability of this failure occurring is extremely unlikely. 2. If the Daily Cleaning Procedure (DCP) fails to complete there is potential for discrepant QC and patient results. The probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting

Recall for Product Correction - Siemens is asking users to follow the detailed instructions in the customer letter.

the DCP. 3. There is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. No erroneous results will be reported. Siemens advises the overall risk to health is low.

3 AUS Recall 01/06/16 Bosco

Medical Australia

Sorbsan Calcium Alignate Dressings (Flat, Ribbon,

Packing, Plus and Border) and Sorbsan Silver Calcium Alignate

Dressing (Flat)

Bosco Medical Australia has become aware of an issue related to the application of an incorrect expiry date to a number of Sorbsan dressings. Product has been labelled incorrectly with a 5 year expiry date instead of a 3 year expiry date. Product effectiveness may be impacted if used past a three year shelf life, and may result in the need to change the dressing more often.

Recall - Bosco Medical is advising customers to inspect stock and quarantine any remaining units of affected stock, for return to Bosco.


Teleflex Medical Australia Pty Ltd

Neonate Resuscitator with Coded Airway & Filter

Resuscitator Kit

Teleflex is recalling the Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit, as the kit was found to contain an incorrect component. The kit should be packaged with a 50mm guedel airway. However, a twin port mask was packed in the kit instead. If a 50mm guedel airway is missing from the package, this may result in a delay of treatment/airway irritation due to sub-optimal size/compromised airway. Given the patient population associated with the use of this device, a delay in resuscitation has the potential to lead to adverse health consequences.

Recall - Users are notified that on receipt of the acknowledgement form a return goods authorisation number will be issued and then a member of the Teleflex team will arrange collection of any affected stock from each facility. A credit will be applied to the customer account for stock returned as part of this recall.

5 AUS Recall 03/06/16 Carl Zeiss

Pty Ltd LumaDent Light Battery

Charger

Carl Zeiss Pty Ltd, following advice from LumaDent is replacing the battery charger of the LumaDent Light. This applies to all charger model numbers, except model number SW-084120. Model number SW-084120, which is the only correct model for all LumaDent batteries BP500 (V3.1, V3.2 and V3.3), is not affected by this recall. The affected battery chargers have not been demonstrated to comply with Australian and New Zealand Electrical Safety Standards

Recall - Carl Zeiss are advising users to inspect all battery chargers and quarantine any batteries which are not model number SW-084120. Carl Zeiss will replace any affected stock.

thus may have the potential to overcharge the batteries causing them to overheat and catch fire. There have been no reports of injuries as a result of this issue.

6 HC Recall 30/05/16

Steris Mexico

790 Avante Ave.,

Industrial Park

Guadalupe, Nuevo Leon

67190 MEXICO

A. AMSCO V-PROL MAX LOW TEMPERATURE STERILZiation

system

Steris has identified that V-PRO 1, V-PRO 1 plus, and V-PRO maX sterilizers manufactured after January 1, 2014 may not display the correct date as of February 29, 16. If users do not manually change the system date of the V-PRO unit, the unit's display and cycle printout will contain an incorrect date. Firm stated only V-PRO maX is sold in Canada.


MEDIX I.C.S.A.

MARCOS SASTRE

1675 BUENOS AIRES, EL

TALAR B1618EWC

ARGENTINA

NATALCARE ST-LX A possible defect in the rolling base of the NatalCare ST-LX incubator which could affect the safety of the product.

8 HC Alert 30/05/16

Bayer Inc. 2920

Matheson Boulevard

East

Mississauga, ON

L4W 5R6 Telephone: 1-800-265-

7382 Email:

canada.medinfo@bay

er.com

ESSURE (permanent birth control system) manufactured

by Bayer Healthcare LLC.

Complications have been reported in some patients with the use of ESSURE (permanent birth control system) including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and various non-specific symptoms suggestive of sensitivity or immune-type reactions. Some complications may be considered serious. In some cases, the extent of the symptoms led to the removal of ESSURE. The removal of ESSURE requires surgery and may include hysterectomy. Post-marketing information suggests that some patients may not always be fully informed of the various possible device and

Important Safety Information - Health Canada has completed a safety review of certain complications associated with the use of ESSURE. Health Canada is working with the manufacturer to update the ESSURE product labelling and to develop a Patient Information Sheet and Checklist. Health Canada will continue to monitor safety information associated with the use of ESSURE and will take action as appropriate if any new safety information is identified.

procedure-related complications before they choose whether to proceed with ESSURE.


Randox Laboratorie

s Ltd. 55

Diamond Road

Ardmore, County Antrim

BT29 4QY UNITED

KINGDOM

A. ALDOLASE MANUAL METHOD

Customers using a Randox RX imola instrument only, will not be able use Randox Aldolase reagent (AD189) with the instrument specific application provided. The parameters shown on the screen shots on the instrument specific application sheet for Aldolase assay on the RX imola instrument are incorrect. The settings do not allow for absorbance change, therefore calibration is not possible, and the assay cannot be run as a test. Affected customers will receive an updated instrument specific application sheet for Aldolase with the correct parameters.

10 HC Recall 31/05/16

BBI SOLUTIONS

OEM LIMITED,

ALCHEMY HOUSE,

TOM MCDONALD AVENUE

MEDIPARK, DUNDEE, DD2 1NH UNITED

KINGDOM

A. SIMPLIRED D-DIMER

Data from long term stability monitoring shows that there is a decline in sensitivity performance of the SimpliRED D-dimer kits containing test reagent 1012-34437. This decline in sensitivity performance may affect qualitative results. False negative results are possible on the SimpliRED D-dimer test which may incorrectly influence the clinical diagnostic decision and could in some circumstances contribute to a delay in the diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE).

11 HC Recall 31/05/16

Bayer Medical Care Inc. 1 Bayer

Drive Indianola

15051-0780

Pennsylvani

a

A. MEDRAD INTEGO PET INFUSION SYSTEM - MAIN

In January 16, a customer complaint reported a mismatch between the prescribed dose value displayed on the screen and the prescribed dose value printed by the printer. The dose activity infused was as intended and printed correctly.

UNITED STATES

12 HC Recall 31/05/16

Diasorin Inc.

1951 Northwestern Avenue,

P.O. Box 285

Stillwater 55082


A. LIASON C. difficile GDH Control set

The liaison C. difficile GDH control set expiration date exceeds the licensed Health Canada shelf life.

13 HC Recall 31/05/16

Shoppers Drug Mart

243 Consumers

Road Toronto

M2J 4W8 Ontario CANADA

A.SHOPPERS DRUG MART ORAL/TOPICAL SYRINGE 10ML B.PHARMAPRIX ORAL/TOPICAL

SYRINGE 10ML

Shoppers Drug Mart/Pharmaprix Oral/Topical Syringe 10ml do not meet the Canadian Medical Device Regulation for labeling requirements.

14 HC Recall 01/06/16

STRYKER SUSTAINAB

ILITY SOLUTIONS 1810 West Drake Dr. Tempe 85283

Arizona UNITED STATES

A. RE-STERILZED ANGIODYNAMICS SOFT-VU

OMNI FLUSH ANGIOGRAPHIC CATHETER

It was reported to Stryker Sustainability Solutions that the tip of two angiographic catheter's model # 10732203 broke off, prior to being used on the patient. During the complaint investigation, visual inspection confirmed that each device had fractured near the distal tip.

15 HC Recall 01/06/16

Roche Diagnostics

GMBH


Mannheim 68305

A.ROCHE HITACHI - GENTAMICIN

B.ROCHE HITACHI - GENTAMICIN

The reason for the recall is related to potential increased recovery of patient results (approximately 15-20%) while using the online TDM Gentamicin assay on Roche cobas c 311, c501/c502, c701/c702 or modular p platforms in combination with Preciset TDM I of specific lots. This issue does not affect the Gentamicin reagent

GERMANY used on the COBAS INTEGRA systems.

16 HC Recall 02/06/16

DRAEGERWERK AG &

CO

MOISLINGER ALLEE 53-

55 LUBECK 23542

GERMANY

A. OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION

HOSE

During the course of routine internal testing, the firm detected isolated episodes of leakage at the check valve (one way valve of the inspiration branch) of the disposable pediatric ventilation hose of Oxylog 3000 system and Oxylog plus, model 5704964. Affected circuits with this fault were potentially distributed to customers. All other ventilation circuits for the Oxylog family of devices are not affected. Leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the same exhaled gas with reduced oxygen concentration/elevated CO2 for the patient. This leakage is not detected during the ventilator operational readiness check.

17 HC Recall 02/06/16

Becton Dickinson

and Company 7 Loveton

Circle Sparks

Maryland UNITED STATES

BD PHOENIXSPEC AP CALIBRATOR KIT

BD has determined that the BD Phoenix Spec Calibrator Kits are labelled with incorrect expiration date. Correct date October 30, 16. Incorrect date printed October 30, 2018

18 HC Recall 03/06/16


Inc. 500 GBC

DRIVE, MAILSTOP 514, P.O. BOX 6101 Newark, Delaware 19714-

6101

DIMENSION VISTA BLOOD UREA NITROGEN

In this follow-up to a February 16 field correction Siemens is expanding the warning of well-to-well accuracy shifts to additional lots (and all future lots until further notice) of Dimension Vista BUN Flex Reagent Cartridges, resulting in inaccurate patient and/or quality/control results. Not all flexes or wells are impacted. Siemens is providing revised advice to customers to manage bun testing.

UNITED STATES

19 HC Recall 03/06/16

ORTHO-CLINICAL

DIAGNOSTICS

FELINDRE MEADOWS, PENCOED, BRIDGEND

A. VITROS Immunodiagnostic Products Total T4 Reagent Pack

Ortho Clinical Diagnostics (Ortho) has initiated this recall because it was determined that the open pack (in use) storage limits must be reduced from 8 weeks to 4 weeks for VITROS Immunodiagnostic products total T4 (TT4) reagent packs. This change affects expired, current (in date) and future product lots.

20 US Recall 31/05/16

ConMed Corporatio

n 525 French

Rd Utica NY 13502-5945

Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-

HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog

Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-

HB13 The ConMed Hip Preservation

System Signature Series is intended to be used for

resection of osseous tissue (bone) in arthroscopic and

endoscopic surgical procedures

Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.

ConMed sent an Urgent Medical Device Recall Notification letter dated December 17, 2015, to all affected customers. Customers are urged to stop use and return these devices immediately. Customers who have further distributed these items are urged to contact all of those organizations immediately and provide a copy of the recall notification letter. It is imperative that all end users of these devices receive the recall notice and respond immediately. Customers with questions can call 315-624-3237 or email [email protected]. The devices should be returned to ConMed Corporation NCR-47057 11155 Concept Blvd. Largo, FL 33773. For questions regarding this recall call 315- 624-3533.

Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales.

21 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3908

Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number:

7319

Compromised sterility due to breach of barrier

Covidien initiated recall by letter on March 4, 16. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway,

Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and UK.

22 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3909

Curity" X-Ray Detectable Laparotomy Sponges, Soft

Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556



Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

23 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3910

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number:

7321



Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway,

Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

24 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3908

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm),

Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding,

absorb fluid, or protect organs.




25 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3909

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray

Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034



Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New

Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

26 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3910

Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch,

4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047




27 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3911

Kerlix X-Ray Detectable Laparotomy Sponges, Tray

Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031



Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe,

Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

28 US Recall 31/06/16

Covidien LLC 60


Haven CT 06473-3912

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray





29 US Recall 31/06/16

Covidien LLC 60


Haven CT 06473-3913

Curity X-Ray Detectable Laparotomy Sponges, Tray




Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France,

Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

30 US Recall 31/06/16

Covidien LLC 60


Haven CT 06473-3914

Curity X-Ray Detectable Laparotomy Sponges, Tray

Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056




31 US Recall 31/05/16

Covidien LLC 60


Haven CT

Curity X-Ray Detectable Laparotomy Sponges, Soft

Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522



Distributed US (nationwide) and the countries of Canada, Austria, Belgium,

06473-3915

Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

32 US Recall 31/05/16

Covidien LLC 60


Haven CT 06473-3916


Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534




33 US Recall 31/05/16

Covidien LLC 60

Middletown Ave


Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545


Covidien initiated recall by letter on March 4, 16. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.

Distributed US (nationwide) and the countries of Canada,

North

Haven CT 06473-3917

Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878

Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

34 US Recall 31/05/16


U.S.A., Inc. 10

Highpoint Dr

Wayne NJ 07470-7431

Endoscope ED-250XT5

Operations Manual: Cleaning Disinfection and Storage

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.


35 US Recall 31/05/16


U.S.A., Inc. 10

Highpoint Dr

Wayne NJ 07470-7432

Endoscope ED-450XT5

Operation Manual: Cleaning, Disinfection and Storage




36 US Recall 31/05/16


U.S.A., Inc. 10

Endoscope ED-250XL5 Operations Manual:

Cleaning, Disinfection




Highpoint

Dr Wayne NJ

07470-7433

37 US Recall 31/05/16


U.S.A., Inc. 10

Highpoint Dr

Wayne NJ 07470-7434

Endoscope; ED-530XT Operation Manual 'Operation and Preparation'

and 'Cleaning, Disinfection and Storage'




38 US Recall 31/05/16


U.S.A., Inc. 10

Highpoint Dr

Wayne NJ 07470-7435

Endoscope ED-450XL5

Operation Manual: Cleaning, Disinfection and Storage




39 US Recall 31/05/16

Skytron, Div. The

KMW Group, Inc

5085 Corporate Exchange

Blvd SE Grand

Rapids MI 49512-5515

EZ Slide Battery/line powered hydraulic table with removable

leg section and 21 top slide General Purpose Surgical Table

Skytron EZ Slide Operating Table

General Purpose Surgical Table

The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the table s elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.

Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 16, to all affected customers. On April 6, 16, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.

Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.

40 US Recall 31/05/16 Abbott

LaboratorieThe ARCHITECT Estradiol Kit

Intended to measure estradiol, Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely

The firm sent a Product Correction letter dated 3/24/16 to all affected consignees describing the nature of the recall as well

Worldwide Distribution --

s

100 Abbott Park Rd

Abbott Park IL 60064-

3502

an estrogenic steroid, in plasma.

elevated estradiol results in patients treated with Fulvestrant.

as instructions to follow. The necessary actions included the following: Consignees are asked to review the letter with their Medical Director. Patients undergoing Fulvestrant therapy should not be tested with the ARCHITECT Estradiol assay. Complete the Customer Reply Form. If the consignee has forwarded the product listed to other laboratories, a copy of Product Correction letter should be provided to them. The customer is asked to retain the letter for their laboratory records. Customers with questions should contact either Customer Service at 1-877-4ABBOTT for the US; or, the local area customer service for outside of the US.

US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK,

ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA,

NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.

41 US Recall 31/05/16 Medscienc

e Inc AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000)

During an FDA inspection it was found that the products are marketed without a

MedScience sent an Urgent Recall letter dated March 28, 16, to their customers to inform them of the product recall. The

Nationwide Distribution to

16469

Bridlewood Cir

Delray Beach FL 33445-6679

and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to

perform up to 72 skin tests. Perform a multi-site skin test

to identify reactions to certain allergens using a non-invasive

applicator that contains 70 different allergens and

histamine.

cleared 510k. letter instructed customers to discontinue and refrain from further use of recalled products and to contact MedScience to arrange the return of products still in possession by the consignee. MedScience set up a phone line and email address for customers to ask questions and obtain further direction: (800) 393-8817 and [email protected].

AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.

42 US Recall 31/05/16

Integra LifeScience

s Corp. 311

Enterprise Dr

Plainsboro NJ 08536-

3344

Integra MicroFrance Monopolar and Bipolar

Electrosurgical Instruments.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 16 to their customers via traceable courier service.

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

43 US Recall 31/05/16


(Cleveland) Inc

595 Miner Rd

Cleveland OH 44143-

2131

Ingenuity Computed Tomography X-ray Systems

Product Usage: Intended to produce cross-

sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

The firm sent a Customer Information letters dated March 8, 16 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia,

Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United

Kingdom, Uzbekistan & Vietnam.

44 US Recall 31/05/16


(Cleveland) Inc

595 Miner Rd

Cleveland OH 44143-

2131

Ingenuity Core 128 Computed Tomography X-ray Systems





Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia,

Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

45 US Recall 31/05/16


(Cleveland) Inc

595 Miner Rd

Cleveland OH 44143-

2132

Ingenuity Core Computed Tomography X-ray Systems,





Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY,

OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal,

Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

46 US Recall 31/05/16


(Cleveland) Inc

595 Miner Rd

Cleveland OH 44143-

2133

Brilliance 64 Computed Tomography X-ray Systems





Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China,

Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

47 US Recall 31/05/16 STERILMED

, INC. 11400 73rd

Reprocessed Microline Scissor Tips intended to be used with a

reusable hand piece and

Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient

Consignees were sent on /26/16 a Sterilmed "Urgent Medical Device Recall" letter dated April 26, 16. The letter was addressed to either Materials Manager, Risk Manager and

US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD,

Ave N Maple

Grove MN 55369-5561

designed for minimally invasive and open surgical procedures

to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model

#'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152,

MIC3162.

injury. Operating Room Director or Distributor. The letter described the problem, the product involved in the recall and the actions required. Advised consignees to immediately quarantine and return the affected product and to complete and return the "Business Reply Form" to Sterilcycle. Advised Distributors to forward the letter to their customers if product was sent to them. For questions contact Sterilmed's Customer Care Team at 1-888-541-0078 .

MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada

48 US Recall 31/05/16

Integra LifeScience

s Corp. 311

Enterprise Dr

Plainsboro NJ 08536-

3344

Integra MicroFrance Monopolar and Bipolar

Electrosurgical Instruments.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 16 to their customers via traceable courier service.

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

49 US Recall 31/05/16

Olympus Corporatio

n of the Americas

3500 Corporate

Pkwy PO Box 610

Center Valley PA

18034-0610

EVIS EXERA Duodenovideoscope Olympus

TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment

monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Models: TJF-160F

and TJF-160VF, all serial numbers

New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.

Olympus notified customers on 03/14/16 via an Urgent Safety Notification letter that referenced discontinuation of previously distributed copies of the TJF-160F/VF Reprocessing Manual. Customers were asked to inspect their inventory and discard any existing inventory of TJF-160F/VF Reprocessing Manuals. They were asked to update their information with the enclosed TJF-160F/VF Reprocessing Manual, which contains new brushing and flushing steps for the TJF-160F/VF elevator mechanisms and the forceps elevator recesses. Instuctions for cleaning and a new cleaning brush (used for cleaning the device) was included with the notification. Customers were asked to ensure all reprocessing personnel are completely knowledgeable and throughly training on the new reprocessing instructions in the new Reprocessing Manual.

Nationwide

50 US Recall 31/05/16

Integra York PA, Inc 589 Davies

Dr York PA 17402-8630

Miltex Premium Grade Self-Lock Chisel Blade Handle,

Catalogue No. 4-405, manual surgical instrument.

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

Integra mailed out an Urgent: Voluntary Medical Device Recall letter to customers informing them to evaluate their inventory for the affected product. If product was shipped to customers, they were asked to identify their customers and to stop shipping immediately. Integra requested that customers complete the attached form that was sent with the notification indicating whether or not they had the affected product on hand and customer service will contact them to provide a Return Authorization number for the product's return. Customers could reach Customer Service at 866-854-

Worldwide distribution. US nationwide, Mexico, and Korea.

8300.

51 US Recall 31/05/16

Baxter Healthcare

Corp 21026

Alexander Ct

Hayward CA 94545-

1234

COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions

to achieve adjunctive hemostasis by mechanically

sealing areas of leakage.

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

52 US Recall 31/05/16

Baxter Healthcare

Corp 21026

Alexander Ct

Hayward CA 94545-

1235







53 US Recall 31/05/16

Baxter Healthcare

Corp 21026

Alexander Ct

Hayward CA 94545-

1236







54 US Recall 31/05/16

Skytron, Div. The

KMW Group, Inc

5085

Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1

Flatscreen Bracket, single monitor mount, 27inch max.

screen size

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

Skytron LLC initiated a voluntary recall of twenty-four monitor brackets used as a mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 3

Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.

Corporate Exchange

Blvd SE Grand


equipment pendant /booms via telephone calls to customers, and written notices sent via certified USPS mail on 04/01/16. All potentially affected users will receive a field correction notification directly from Skytron, LLC along with the contact information of their local Skytron distributor. Skytron distributors must contact identified users within the universe of affected products to schedule a time replace the affected monitor bracket(s). Skytron will provide a replacement of the monitor bracket. The replacement monitor bracket(s) and installation must be conducted by you, the Skytron distributor. The affected monitor bracket(s) and Service Report indicating that the monitor bracket(s) was replaced must be returned to Skytron. Please contact Larry Perez, Vice President of Technical Services, at 616-656-1187 or [email protected], or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or [email protected] with any questions. For after-hours support, please call 1-800-SKYTRON.

55 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N Plymouth

MN 55441-4575

Torque Limiting Adapter: Torque Limiting Attachment,

Non Sterile, Distributed by Zimmer.

PRECIMED, Torque Limiting Adaptor, Non Sterile..

Customer Number/Model: 00-2360-080-00 T10232,

T116245 T116245, TLA025-25 TLA025-25,

00-2360-080-05 T10233, MAC21003 T116430, TLA025-

30 TLA025-30, MAC21001 T112972,

MAC21001 T13621, TLA025-20 TLA025-20.

Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.

Consignees were sent on 4/26/16 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 16. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail [email protected].

US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

56 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N Plymouth

MN 55441-4575

Torque Limiting Handle: PRECIMED, T-Handle Torque,

Non Sterile. Handle:

Customer Number/Model: MCL120014 T14000, TLT911-

50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01,

Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the



TLTS0007-20-S19 TLTS0007-20-

S19, TLT911-35-S01 TLT911-35-S01.

device.

57 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N Plymouth

MN 55441-4576

Torque Limiting Screwdriver: Greatbatch Medical, Torque

Limiting Driver, Non Sterile, Rx Only.

PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only.

Screwdriver: Customer Number/Model:

804-03-038 T11623, T14001 T14001, MTO35173507

T14378, MTO375173506 T14379, MTO35173505

T14380, MTO35175303 T8127.




58 US Recall 01/06/16

Orthofix, Inc

3451 Plano Pkwy

Lewisville TX 75056-

9453

Firebird NXG Spinal Fixation System Set Screw Driver used

to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

There is a possibility that the subject set screw driver could disengage from the

torque limiting handle when the counter torque wrench is allowed to contact the

counter torque handle.

Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.

KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA

59 US Recall 01/06/16

Ventlab LLC 2710

Northridge Dr NW Ste

A Grand


STAT-Check Resuscitation Bag Manual Emergency

Resuscitation Bag with Carbon dioxide gas analyzer

Intended for use in various clinical situations to provide

respiratory support in the presence of reversible apnea

commonly associated with respiratory arrest. The device

should only be used by personnel trained in CPR

procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for

verification of successful ventilation / intubation in

patients > 2.2 kilograms (5lbs.).

Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 16, on March 15, 16, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at [email protected].

Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.

60 US Recall 01/06/16 Natus Replacement HEPA filter for The replacement HEPA Filters have been Natus sent an " URGENT RECALL NOTIFICATION/ FIELD distributed in

Medical

Incorporated

5900 1st Ave S

Seattle WA 98108-3248

Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue

Part Number: 54343, 54344, and 100105-01.

manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.

SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 16) was sent to all affected customers on May 2, 16. for the first set of customers and then sent on May 12, 16, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter " if the serial number is one of the 21 shown as affected serial numbers on the letter. The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 16 and released on May 12, 16,) was sent to customers on May 16, 16, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier " if it contains a HEPA filter that is identified with one of 21 affected serial numbers. Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber. Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter. Please contact Natus at [email protected] or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.

the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.

61 US Recall 01/06/16

Leica Microsyste



Novocastr Liquid Mouse Monoclonal Antibody CDX2

(CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.

An Urgent: Medical Device Recall Notification dated 4/5/16 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent¿ Complete the attached Recall Notification Acknowledgement Form that this action has been undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to [email protected] to receive credit for affected lots that have been destroyed by the consignees laboratory.

Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.

62 US Recall 01/06/16

Leica Microsyste



Novocastr Liquid Mouse Monoclonal Antibody Renal

Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the

definition of tumors of proximal nephrogenic

differentiation.

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.



63 US Recall 01/06/16


Inc. 101

Silvermine Rd

Brookfield CT 06804-

2047

Dimension Vista 500 Intelligent Lab System running on

software versions V.3.6.1 SP1 or V.3.6.2, Device listing #

D011374, All serial numbers and lots are affected.

The Dimension Vista System is an in vitro diagnostic device

intended to duplicate manual analytical procedures such as

pipetting, mixing, heating, and measuring spectral intensities

to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications

use photometric, turbidimetric, chemiluminescence,

nephelometric and integrated ion-selective multisensor technology for clinical use

Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

Siemens sent an Urgent Medical Device Correction letter dated March 24, 16, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

64 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N

Torque Limiting Adapter: Torque Limiting Attachment,

Non Sterile, Distributed by Zimmer.

PRECIMED, Torque Limiting

Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque

Consignees were sent on 4/26/16 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 16. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the


Plymouth

MN 55441-4575

Adaptor, Non Sterile. limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.

Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail [email protected].

65 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N Plymouth

MN 55441-4575

Torque Limiting Handle: PRECIMED, T-Handle Torque,

Non Sterile.




66 US Recall 01/06/16

Greatbatch Medical

2300 Berkshire

Ln N Plymouth

MN 55441-4575

Torque Limiting Screwdriver: Greatbatch Medical, Torque

Limiting Driver, Non Sterile, Rx Only.

PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only.




67 US Recall 01/06/16

Orthofix, Inc

3451 Plano Pkwy

Lewisville TX 75056-

9453

Firebird NXG Spinal Fixation System Set Screw Driver used

to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.

Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.

KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA

68 US Recall 01/06/16

Ventlab LLC 2710

Northridge Dr NW Ste

A Grand


STAT-Check Resuscitation Bag Manual Emergency

Resuscitation Bag with Carbon dioxide gas analyzer

Intended for use in various clinical situations to provide

respiratory support in the presence of reversible apnea

commonly associated with respiratory arrest. The device

should only be used by personnel trained in CPR

procedures. The ACE/STAT-

Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 16, on March 15, 16, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at [email protected].

Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.

Check II is intended for use as an adjunct assessment tool for

verification of successful ventilation / intubation in

patients > 2.2 kilograms (5lbs.).

69 US Recall 01/06/16

Natus Medical

Incorporated

5900 1st Ave S

Seattle WA 98108-3248

Replacement HEPA filter for Natus Sterile-Drier Model 43

and Model 44. Filter Catalogue Part Number: 54343, 54344,

and 100105-01.

The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.

Natus sent an " URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 16) was sent to all affected customers on May 2, 16. for the first set of customers and then sent on May 12, 16, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter " if the serial number is one of the 21 shown as affected serial numbers on the letter. The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 16 and released on May 12, 16,) was sent to customers on May 16, 16, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier " if it contains a HEPA filter that is identified with one of 21 affected serial numbers. Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber. Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter. Please contact Natus at [email protected] or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.

Distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.

70 US Recall 01/06/16

Leica Microsyste



Novocastr Liquid Mouse Monoclonal Antibody CDX2

(CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.

An Urgent: Medical Device Recall Notification dated 4/5/16 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent¿ Complete the attached Recall Notification Acknowledgement Form that this action has been


undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to [email protected] to receive credit for affected lots that have been destroyed by the consignees laboratory.

71 US Recall 01/06/16

Leica Microsyste



Novocastr Liquid Mouse Monoclonal Antibody Renal

Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the

definition of tumors of proximal nephrogenic

differentiation.

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.



72 US Recall 01/06/16


Inc. 101

Silvermine Rd


2047

Dimension Vista 500 Intelligent Lab System running on

software versions V.3.6.1 SP1 or V.3.6.2, Device listing #

D011374,

Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

Siemens sent an Urgent Medical Device Correction letter dated March 24, 16, to all affected customers. Customers were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

73 US Recall 01/06/16 Siemens

Healthcare Dimension Vista 1500

Intelligent Lab System running Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens

Siemens sent an Urgent Medical Device Correction letter dated March 24, 16, to all affected customers. Customers

Nationwide Distribution to

Diagnostics

Inc. 101

Silvermine Rd


2048

on software versions V.3.6.1 SP1 or V.3.6.2, Device listing #

D011374

Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.

were advised to follow the instructions contained in the "Urgent Medical Device Correction" notification letter to help minimize or eliminate the impact that this specific software defect could cause until a software correction could be made (i.e instructions to minimize the impact of the software defect due to "Bad Sample Detect " False Transition" errors when processing front loaded samples) and (how to eliminate the impact of the software defect when processing front loaded samples). Customers were also asked to review the recall notification letter with their Medical Director and complete and return the Field Correction Effectiveness Check Form within 30 days. Customers with questions were advised to contact Siemens Customer Care Center - Technical Solutions at 800-441-9250 or their local Siemens technical support representative. For questions regarding this recall call 302-631-8248.

AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

74 US Recall 01/06/16

Windstone Medical

Packaging, Inc.

1602 4th Ave N

Billings MT 59101-1521

Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical

instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic

Kerlix X-Ray Detectable Laparotomy Sponges.

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 16, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remaining inventory. Consignees should return the Reply Form via fax at 407-865-7456 or call 321-527-7714 for any questions about this recall.

Nationwide distribution to Louisiana and Montana.

75 US Recall 01/06/16

Windstone Medical

Packaging, Inc.

1602 4th Ave N


General Surgery Pack, part number 006880-3. This is a

custom convenience surgical instrument disposable kit.

There are multiple component in this kit and the recalled item subject to recall is Medtronic

Kerlix X-Ray Detectable Laparotomy Sponges.




76 US Recall 01/06/16

Windstone Medical

Packaging, Inc.

1602 4th Ave N


Laparotomy Pack, Part numbers 006268-8 and

007725-8. This is a custom convenience surgical

instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic

Kerlix X-Ray Detectable Laparotomy Sponges, Tray

Pack, 8" x 32" W/L.




77 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct

Gainesville FL 32653-

1630

Novation Press-Fit Splined, Standard Offset, HA Coated,

12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip

arthroplasty.

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Customers were notified 4/12/16 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

78 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct


1631

Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip

arthroplasty.


Customers were notified 4/12/16 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue,


please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)

79 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct


1632

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.




80 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct


1633

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.




81 US Recall 02/06/16 B. Braun Medical,

Inc.

Non-Vented Dispensing Pin with One-Way Valve and Luer

Lock Ultrasite Valve

BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have

B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of

US Nationwide Distribution in the states of:

901

Marcon Blvd

Allentown PA 18109-

9512

Product Usage: Used for aspiration of

medication from inverted bags or semi-rigid containers. Interavenous delivery of

transferred medication(Device is not intended for direct

infusion)

been identified in the blister package paper, where the unit label writing is located.

the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: [email protected] and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.

AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico

82 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct


1633

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated,

54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip

arthroplasty.




83 US Recall 02/06/16

Exactech, Inc.

2320 NW 66th Ct


1634

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated,

56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip

arthroplasty.


Customers were notified 4/12/16 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you


have any inventory restocking questions related to this issue, please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)

84 US Recall 02/06/16

B. Braun Medical,

Inc. 901

Marcon Blvd

Allentown PA 18109-

9512

Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve

Product Usage: Used for aspiration of

medication from inverted bags or semi-rigid containers. Interavenous delivery of

transferred medication(Device is not intended for direct

infusion)

BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.

B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: [email protected] and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.

US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico

85 US Recall 02/06/16

Elekta, Inc. 400

Perimeter Center Ter NE Ste 50

Atlanta GA 30346-1227

Monaco RTP System Product Usage:

The Monaco system is used to make treatment plans for

patients with prescriptions for external beam radiation

therapy.

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.

Field Safety Notice 382-01-MON-004 was sent to customers on May 18, 16. The notice informs users of the specific product and version numbers affected by both issues, and any work around that can be used to avoid the issue. The customers were instructed to complete and return the Field Safety Notice Acknowledgement form to their local Elekta as soon as possible.

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus,

Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe

86 US Recall 03/06/16

Sedecal USA, Inc.

230 Lexington

Sedecal SA Mobile Diagnost w DR x-ray system

Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type "

Sedecal USA has developed a new software release to address this issue. The distributor of this product, Philip, will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and

US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ,

Dr

Buffalo Grove IL 60089-6930

Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.

initiate a software update to correct the two defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (847) 394-6960.

GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.

87 US Recall 03/06/16

Stryker Corporatio

n 5900


95138-1400

Stryker FlowPort II Adapter: Model number: 00CAT00778

The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to

commercially available, 4mm arthroscopes in surgical

procedures.

Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction

A recall letter was not sent as all affected devices have been returned. A ship hold was placed on the device on October 16, 2015.

GA, UT, MD, NJ, MT

88 US Recall 03/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1032

Philips Healthcare DuraDiagnost stationary X-ray

system

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.

USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

89 US Recall 03/06/16

Hospira Inc. 275 N Field

Dr Lake Forest IL 60045-

2579

Firm's investigation determined that the Proximal Occlusion Alarms observed in

the field were attributed to the mechanism calibration process being performed with an out of

specification metal cassette, resulting in an offset in

proximal pressure.

The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or

epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery

from one or more rigid or flexible fluid containers. The Plum 360 infuser features

Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows

two lines to be delivered at independent

Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 16, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if

U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and

rates. The volume to be infused (VTBI) is

delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering

I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as

removing proximal air in line, without is disconnecting the patient line. The Plum 360 can act as a stand-alone infuser, or in

conjunction with the Hospira MedNet software to provide medication safety

software at the point of care, with customized drug libraries to support

hospital defined protocols by clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art

wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and Hospira MedNet

software interface with other hospital systems such as Electronic Health records,

Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and there systems. Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and

wireless 802.11 a/b/g/ networking capabilities. The Plum 360 infuser interfaces with Hospira MedNet application software

to download drug library and infuser software updates and enable auto-

programming of the infuser. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion

line and to activate an alarm.

you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue.

Uruguay.

90 US Recall 03/06/16

Philips Healthcare

3000 Minuteman

Rd

Philips Healthcare DigitalDiagnost stationary X-ray

system

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the

USA (nationwide) Distribution to the states of : ( DuraDiagnost)

Andover

MA 01810-1032

software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.

to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

91 US Recall 03/06/16

Affymetrix Inc

26111 Miles Rd

Warrensville Heights

OH 44128-5933

CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash

buffers (WS), a microarray kit, and analysis software.

During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.

A letter dated April 14, 16 was sent to customers. The letter stated the reason for the recall. It also informed customers that there is no impact on the performance of the assay. Customers were asked to either visit the IVD web portal (www.affymetrix.com/ivd) and review the warning statements; or, request a hard copy free of charge.

Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.

92 US Recall 03/06/16

Hospira Inc. 275 N Field

Dr Lake Forest IL 60045-

2579

The Plum A+ is a dual-line volumetric infusion system

designed to meet the growing demand for hospital-wide, as

well as alternate site and home healthcare, standardization.

With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide

range of medical/surgical and critical care applications. Full compatibility with LifeCare

Plum Series administration sets and accessories.

Each system includes a pumping module (hereafter

called the infuser) and an assortment of disposable IV sets (hereafter called a set),

and optional accessories. The Plum A+ host device contains a

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.

Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 16, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue.

U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.

Connectivity Engine peripheral

module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked

application software to download drug libraries to the

infuser and enable the autoprogramming

feature.

93 US Recall 03/06/16

Integrated Science

Systems Inc 1215

George C Wilson Dr

Unit A4 Augusta GA

30909-5700

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T,

Sure Vue SELECT Staph, biokit SELECT Staph 75T

The product is used as an aid in the identification of

Staphylococcus aureus from Culture

Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

Integrated Science Systems sent a Recall Notification letter dated March 29, 16. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.

Nationwide distribution to CA only.

94 US Alert 01/06/16

Sorin Group

Deutschland GmbH

Stӧckert 3T Heater-Cooler System (3T)

The FDA is providing new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in patients who have undergone cardiothoracic surgeries.

Recommendations for Health Care Facilities and Staff In addition to the recommendations provided in the 2015 Safety Communication for facilities and staff using heater-cooler devices, the FDA recommends the following: •If your facility purchased and used the 3T prior to September 2014, be aware the units may have been shipped from the factory contaminated with M. chimaera. Such facilities should: ◦inform health care providers who have performed cardiothoracic surgeries, that there is a possibility that their patients may have been infected with M. chimaera. Reports to date suggest there may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. ◦determine a method for patient follow-up and establish patient surveillance in cases of potential exposure, per the recommendations in CDC’sInterim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units. •If you purchased and used the 3T after September 2014: ◦continue to follow the recommendations provided in FDA’s

2015 Safety Communication and the manufacturer’s most current Instructions for Use for cleaning, disinfecting and maintenance to reduce the risk to patients. During the upcoming June 2-3, 16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will seek expert clinical opinion and recommendations for patient notification and patient follow-up procedures. Recommendations for sampling and monitoring of the 3T and other heater-cooler devices will also be discussed. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate. Recommendations for Patients •Be aware that: ◦in the U.S., cardiopulmonary bypass procedures involve the use of a heater-cooler device. ◦the FDA has received reports of patient infections associated with exposure to M. chimaera when a contaminated 3T (heater-cooler device) was used during surgery. ◦there may be an increased risk of infection if you received a heart valve, graft, LVAD or any other prosthetic product/material or had a heart transplant. ◦during the upcoming June 2-3, 16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will seek clinical opinion about the risk of patient infection with NTM associated with the use of heater-cooler devices and mitigation strategies. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate. •If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of NTM infection. These may include: ◦fatigue ◦difficulty breathing ◦persistent cough or cough with blood ◦fever ◦pain ◦redness, heat, or pus at the surgical site ◦muscle pain ◦joint pain ◦night sweats ◦weight loss ◦abdominal pain ◦nausea

◦vomiting •If you have undergone a cardiopulmonary bypass procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider as soon as possible. •If you are not currently experiencing any changes in your general health, inform your health care provider during your next wellness visit that you have undergone a cardiopulmonary bypass procedure to determine if you require further testing or monitoring for possible exposure to NTM. Additional information for patients is available on FDA’s Heater-Cooler Devices "Information for Patients" webpage. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.

95 SA Recall 29/05/16 Medtronic

Inc PSS Midas Rex Sagittal Saws

Medtronic testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

Medtronic will contact Health Care Professionals informing about a voluntary filed action to remove all Midas Rex Sagittal Saws from market.

96 SA Recall 29/05/16 Abbott ACCELERATOR Automated Processing System (APS)

Abbott Diagnostics has been notified that the manufacturer of the centrifuge recommends an immediate reduction in the operating speed of the centrifuge not to exceed a maximum of 3500 RPMs. Material changes may have had an impact on the bucket strength, which could lead to the bucket becoming dislodged in the centrifuge

Immediately reduce the maximum RPMs to 3500. Visually inspect your centrifuge buckets for cracks If any cracks are identified OR if the “useable until” date has expired, immediately stop using the centrifuge. Contact Customer Service to arrange for replacement buckets. Continue to perform Weekly Maintenance per the ACCELERATOR APS Operations Manual (580799015.0, September 2014).

97 SA Recall 01/06/16 GE

Healthcare

3.0T 6-Channel Flex Coils Used with Discovery MR750 3.0T

Scanners Running DV24, DV25, or DV25.1 Application Software

The current versions of MR750 DV24, DV25, and DV25.1 software could allow for 3.0T 6 Channel Flex Coil overheating when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury.

GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.

98 SA Recall 01/06/16 Ethicon

Endo Surgery Inc

ETHICON PHYSIOMESH Flexible Composite Mesh

Ethicon has initiated a voluntary product recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed

Examine your inventory immediately to determine if you have product subject to this action on hand and quarantine such product(s). Remove the product subject to this voluntary product recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return.

German Registry and Danish Hernia Database-DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH™ Composite Mesh from the global market.

Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and provide a copy to manufacturer within three (3) business days. Please return the BRF even if you do not have product subject to this action. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. Customers are required to return all unexpired ETHICON PHYSIOMESH™ Composite Mesh products that are in their inventory immediately. Only unexpired product subject to this recall returned by September 16, 16 will be credited to your account. Expired product that is returned after that date will not be reimbursed.


LIST

1 AUS Alert 06/06/16 Medtronic Australasia

Pty Ltd

Medtronic deep brain stimulation (DBS) devices

Medtronic has become aware of a reported event of inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer. Information will be added in the future to Medtronic’s Deep Brain Stimulation (DBS) labelling in relation to loss of co-ordination, including the inability to swim.

Hazart Alert - Medtronic is advising surgeons and patients to be aware that loss of coordination may be a side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood. Medtronic is also updating the product labelling to include information in relation to the loss of coordination. For more information, please see https://www.tga.gov.au/alert/medtronic-deep-brain-stimulation-devices-multiple-models .


Australia Pty Ltd

PowerPro Ambulance Cots

Stryker has become aware that the supplier has made a manufacturing transfer from their Tier Two supplier which affected the quality of the boards supplied to Stryker. As a result of workmanship issues, the boards have the potential to short circuit and

Recall for Product Correction - Stryker is advising users to inspect stock for the affected lot numbers. Any affected devices will be corrected, and can continue to be used until the correction has been completed.

overheat. There is a high probability of limited (minor, transient) harm, specifically minor respiratory irritation, not requiring medical intervention and untended lowering or cot dropping to the lowest position (no cot tip). Faulty units will not work as intended. There have been no reports of injury associated with this issue.

3 AUS Recall 07/06/16 Medtronic Australasia

Pty Ltd

Medtronic Reveal LINQ Insertable Cardiac Monitor

(ICM)

In February 16, Medtronic issued a Medical Device Hazard Alert communication that indicated Medtronic Reveal LINQ Insertable Cardiac Monitors (ICMs) could experience a performance issue that affects the Recommended Replacement Time (RRT) alert. This original communication named Phase 1, also explained that Medtronic was awaiting a software update to address this issue. Medtronic has now developed the necessary software and is ready to begin applying this update to all Reveal LINQ ICMs which constitutes Phase 2 of the alert. Once installed, this software update will reset RRT & End of Service (EOS) status and re-enable wireless transmissions for devices that have experienced premature RRT /EOS. The update will also prevent the occurrence of premature RRT alerts due to this issue. Refer to the original communication for additional details (RC-16-RN-00202-1).

Recall for Product Correction - Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor .

4 AUS Recall 08/06/16 Maquet Australia Pty Ltd

STATLOCK IAB Stabilisation Device

(offers needle-free securement for intra-aortic balloon (IAB)

catheters)

During post-quarantine packaging it was identified that the IFU for the STATLOCK Sheath Stabilisation Device for Percutaneous Sheath Introducers was erroneously packaged with the MEGA and SENSATION PLUS IAB Catheter Kits, instead of the IFU for the STATLOCK Catheter Stabilisation Device for IAB Catheters.

Recall for Product Correction - Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative.


Emergo Asia Pacific Pty Ltd T/a

Emergo

RaySearch RayStation 5 (Radiation therapy treatment

planning system)

This notice concerns an issue found with the treatment plan report in RayStation 5. For a treatment plan with multiple beam sets, the table for region of interest (ROI) plan dose

Recall for Product Correction - Users are advised to inspect all report templates that are intended to be used for plan with multiple beam sets, and to ensure that "POI Dose Statistics (Plan)" is included immediately before "ROI Dose statistics

Australia statistics in the report may show the

statistics for a beam set dose instead of the plan dose. In the case where a clinical decision is based on the erroneous ROI plan dose statistics, a patient could potentially receive a higher than acceptable radiation dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. For such a report template, all reports for multiple beam set plans would always be affected.

[Plan dose]" in the report content area. A software upgrade will be implemented as a permanent correction.

6 AUS Recall 08/06/16 Kerr

Australia Pty Ltd

Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental

restoration)

Kerr Australia is recalling certain lots of Herculite Ultra, Herculite XRV, Point 4, and Premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. The particulate is visible to Doctors and should be easy to remove prior to or even after curing. The particulate is unlikely to cause any adverse health consequences.

Recall - Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.

7 AUS Recall 08/06/16 Hill-Rom Pty Ltd

Compella Bariatric Bed System, Controllers and Air Surfaces

Hill-Rom has become aware of a potential issue with some Compella Air Supply Units and Air Surfaces. The Compella Air Supply Unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. This also prevents the low air loss feature from operating. In addition, within the Low Air Loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure.

Recall for Product Correction - A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly.


Healthcare Pty Ltd

Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used

with Dimension Vista System). An in vitro diagnostic medical

device (IVD)

In February 16, Siemens Healthcare Diagnostics issued a letter, informing customers of well-to-well accuracy shifts for specific lots of Dimension Vista BUN causing inaccurate patient and/or Quality Control

Recall for Product Correction - Siemens is providing work around instructions to users to follow in order to detect the affected reagent well sets. The actions are strongly recommended to minimise the usage of affected reagents wells. Additionally, users are advised to discard any reagent

results. Preliminary investigation demonstrated loss of enzymatic activity of the GLDH reagent wells made from a specific mold/cavity. Siemens have since confirmed there is an additional cause of reduced GLDH activity. · If calibration is performed using an unaffected well and samples are tested using an affected well, BUN results may be falsely depressed by up to approximately 50% across the concentration range of 11 – 784 mg/dL. QC will detect the issue. · If calibration is performed using an affected well and samples are subsequently tested using an unaffected well, BUN results may be falsely elevated by up to approximately 64% across the concentration range of 15 – 740 mg/dL. There may be in the delay in the follow-up for kidney disease.

cartridges with cavity number B4. Siemens is not recommending a review of previously generated results however, a review due to this issue is at the discretion of the laboratory director


Fisher & Paykel

Healthcare Pty Ltd

AIRVO 2 / myAIRVO 2 Humidifier

Fisher & Paykel has updated the AIRVO 2 / myAIRVO 2 User Instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.

Recall for Product Correction - Fisher & Paykel are advising users that the AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to check speaker functionality before each patient use, using the steps in the User Instructions. First turn the unit on and then remove the heated breathing tube. The user should see the “check tube” visual signal and hear the speaker signal. If either signal is absent, users are advised not to use the unit and contact their Fisher & Paykel representative to arrange for a replacement device.


Australia Pty Ltd

Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)

Stryker Neurovascular has become aware that some units of the Target Nano Detachable coils do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching. The most likely adverse health consequence from coil stretching is prolongation of the procedure, as the stretched coil needs to be removed from the patient and replaced.

Recall - Stryker is advising users to inspect stock and quarantine any remaining affected units for return.

There is a potential of thrombus formation when the stretched coil is left exposed in the blood flow. Additional intervention may be required to snare the stretched coil or pin it to the vessel wall with a stent if safe removal is not possible. This may result in thrombus or thromboembolism which can lead to stroke. There will be no long term adverse health consequence after a stretched coil is removed from the body.


GE Healthcare Australia Pty Ltd

Discovery MR750w (MRI System)

GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. This issue has been observed in the situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels. There have been no reports of injury as a result of this issue.

Recall for Product Correction - GE is advising users to continue to use the system and follow the existing Operator Safety Information for proper patient padding and observation during scanning. If a brown discolouration is seen on the inner surface of the patient bore or if a burning smell is noticed, discontinue scanning. GE will be correcting all affected units.

12 AUS Recall 10/06/16 Amplitude Australia Pty Ltd

Score Extension Stem for Total Knee Prosthesis - Cemented

Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. The pouches function as the sterile barrier of the device packaging. There is a risk of infection if a patient is implanted with a non- sterile implant. The implantation of non-sterile device is unlikely. The routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device.

Recall - Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.

13 AUS Recall 10/06/16 Merck Pty

Ltd

Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the

stomach prior to tube feeding)

Merck has received a product complaint regarding concerns of colour indications on packaging being insufficiently clear and the possibility of end users confusing the colour

Recall - Merck is advising users to inspect stock and remove any remaining strips of the affected lots from use. Affected stock will be replaced with a revised indicator strip or a credit note issued.

coding in the explanatory box with the corresponding colour on the pH strip. Please note that with these pH indicator papers, the printed scale on the packaging serves purely as an instruction on how to use the product. The pH is only identified by comparison of the test square with the printed colours on the test strip itself.


Beckman Coulter

Australia Pty Ltd

ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro


Previously unknown drug interferences from Sulfasalazine and Sulfapyridine have been identified. There is a possibility that drug interference's from administration of Sulfasalazine to patients may generate false low ALT results and false low Glucose-Stat results. Sulfapyridine may generate false high Glucose-Stat results (OSR6X40). Interference seen with 300mg/L Sulfasalazine showed a negative bias of up to 35% for the low ALT control and up to 29% for the high ALT control. Interference seen with 300mg/L Sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/L) for the low Glucose-Stat control and up to 13% (or 1.6mmol/L) for the high Glucose-Stat control. Interference seen with 300mg/L Sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/L )for the low Glucose-Stat control and up to 9% or (1.1mmol/L) for the high Glucose-Stat control. There is no risk to patients however there is the potential for a delay in results.

Recall for Product Correction - Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended.

15 HC Recall 06/06/16

Howmedica Osteonics Corporatio

n 325

Corporate Drive

Mahwah New Jersey

UNITED

A. TRIDENT CONSTRAINED LINER IMPACTOR TIPS

During steam sterilization validation it was discovered that the TRIDENT Constrained Liner Impactor Tips do not meet the required Sterility Assurance Level (SAL) of 10-6. Please note that these instruments are sterilized at the hospital prior to surgery, however, and do not come from Stryker sterile.

STATES

16 HC Recall 06/06/16

Smith & Nephew

Inc. 1450

Brooks Road

Memphis, Tennessee

38116 UNITED STATES

A. LEGION HINGE KNEE (HK) FEMORAL ASSEMBLY

Smith & Nephew, Inc. Has initiated a voluntary field safety corrective action of the LEGION HK femoral assembly due to a manufacturing issue. The surface inside of the femoral component, where cement is applied for adhesion, is out of specification. The expected surface roughness is 200-325 ra. The affected devices are below allowable limits for surface roughness.

17 HC Alert 06/06/16

Carefusion 303, Inc. 10020 Pacific

Mesa Blvd. San Diego

92121-2733

California UNITED STATES

A. Alaris PC Unit Model 8015. Software v9.17 and 9.19

Software error will cause device to over or under dose patient. This error occurs if operator uses the restore feature under certain circumstances

18 HC Recall 08/06/16

Stryker Neurovascu

lar 47900 Bayside Parkway Fremont


A. TARGET 360 NANO DETACHABLE COIL

B. TARGET 360 NANO DETACHABLE COIL

Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.

19 HC Recall 09/06/16

Synthes USA LLC

1101 SYNTHES AVENUE

Monument 80132

Colorado

TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT

B. TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT

FOOT C. TI SINGLE VECTOR

DISTRACTOR PROXIMAL FOOT/RIGHT

The fastener on the mandible distractor may become prematurely separated from the proximal foot plate.

UNITED STATES

D. TI SINGLE VECTOR DISTRACTOR PROXIMAL

FOOT/LEFT

20 HC Recall 09/06/16

Bomimed Inc.

1-100 IRENE

STREET Winnipeg R3T 4E1

Manitoba CANADA

A. Feather-flex 6 inch disposable ventilator freeze

flex tube

The label description on the individual bag incorrectly states 12", instead of 6".

21 HC Alert 09/06/16 N/A Unauthorized products

As part of Health Canada's ongoing commitment to help protect the health and safety of Canadians, the department again partnered with the Royal Canadian Mounted Police, the Canada Border Services Agency and the International Criminal Police Organization (INTERPOL) for the ninth consecutive year of Operation Pangea. Operation Pangea is a global effort to disrupt the online sale of counterfeit and unlicensed pharmaceutical products and medical devices. It focuses on stopping illegal health products from reaching the Canadian market. Activities included border blitzes, compliance verification of websites selling health products to Canadians and education and outreach activities. This year's operation took place from May 30-June 7, 16 and was the largest of its kind so far. 103 countries and 193 police, customs, and health regulatory agencies participated worldwide and resulted in a record number of illicit and counterfeit health products being seized. Health Canada inspected 4,227 packages, refused 2,576 packages and seized 1,283 packages containing counterfeit or unlicensed health products at the border during this week of action. Among the health products seized or

refused during this year's operation were unauthorized weight loss and sexual enhancement products, and an unauthorized hair removal device.. The vast majority of these, 98%, were sexual enhancement products that were either fake or unauthorized. Health Canada has previously communicated on the risk of buying drugs, natural health products or medical devices online. When Health Canada identifies or is advised of Internet sites selling illegal health products, the Department takes action to protect the health and safety of Canadians. The results of this year's Operation Pangea are a reminder that you may be putting your health at risk by buying health products online. Health products available online may look like the products you use every day but they may not have been reviewed by Health Canada for safety, quality and effectiveness. They may contain hidden ingredients not listed on the label, dangerous additives and/or contaminated ingredients. In addition, they may lack the active ingredients Canadians would expect them to contain to help maintain and improve their health. For all of these reasons, they could cause serious health effects. The healthycanadians.gc.ca website contains information about illegal health products that have been found on the Canadian market. Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

22 HC Recall 10/06/16

Pro-Lab Diagnostics

3 Bassendale

Road

A. Salmonella Agglutinating Serum O poly A-S

The overall performance of the antisera has deteriorated and this is more marked in some factors than others. The product was deemed not fit for purpose as it had deteriorated since being put on the market. It was still agglutinating with most

Bromborou

gh, Merseyside CH62 3QL UNITED

KINGDOM

salmonella cultures tested against, but was slower against some of the higher somatics, as it is not detecting within one minute which is stated in the instructions for use.

23 HC Recall 10/06/16

MEDIN MEDICAL

INNOVATIONS GMBH,

ADAM-GEISLER-

STRASSE 1, OLCHING

82140 GERMANY

A. MEDIJET NCPAP GENERATOR

Pressure variations generated under different circumstances (e.g. heated air flows).

24 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1032

Philips Healthcare Brilliance iCT Computed Tomography X-Ray

System

Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (1-800) 722-9377, Option 5

US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.

25 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1033

Philips Healthcare Brilliance 64 Computed Tomography X-Ray

System




26 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Philips Healthcare Ingenuity Core Computed Tomography X-

Ray System

Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3)

Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and

US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY,

Rd

Andover MA 01810-

1034

scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (1-800) 722-9377, Option 5

NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.

27 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1035

Philips Healthcare Brilliance iCT SP Computed Tomography X-

Ray System




28 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1036

Philips Healthcare Ingenuity Core128 Computed

Tomography X-Ray System




29 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1037

Philips Healthcare Ingenuity Elite Computed Tomography X-

Ray System




30 US Recall 06/06/16 Synthes (USA)

DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm,

Devices did not pass the biological safety evaluation for cytotoxicity following

Depuy Synthes sent an Urgent Notice: Medical Device Recall letter on 05/02/16 to all affected consignees. Consignees

US nationwide distribution.

Products

LLC 1301

Goshen Pkwy West


Orthopedic manual surgical instrument. Part number

351.43

exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

were instructed to do the following: review your inventory immediately to see if any of the affected products were being stored, and call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement order, to complete the Verification Section (page 3) and return with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.

31 US Recall 06/06/16

Philips Healthcare

3000 Minuteman

Rd Andover

MA 01810-1032

Philips Healthcare Ingenuity CT Computed Tomography X-Ray

System




32 US Recall 06/06/16

GE Healthcare,

LLC 3000 N

Grandview Blvd

Waukesha WI 53188-

1615

GE Revolution CT The system is intended for

head, whole body, cardiac and vascular X-ray Computed

Tomography applications. The system is intended to produce cross-sectional images of the

body by computer reconstruction of x-ray

transmission projection data from the same axial plane taken at different angles.

GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter ,GEHC Ref# 25468, dated May 9, 16 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions; continue to use your Revolution CT product; follow the Patient Positioning warning outlined in the Revolution CT User Manual; to prevent pinching or crushing of the patients extremities, keep the patients hands and feet away from the edge of the moving table top/cradle and its surrounding equipment, or between table base and side panels of the table; and take special care when positioning physically large patients. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico,

New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.

33 US Recall 06/06/16

Ortho-Clinical


Rochester NY 14626-

5101

VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device

Identifier No. 10758750002740; and VITROS

5600 Integrated System (refurbished), Catalog Number

6802915, Unique Device Identifier No.

10758750007110; IVD.

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

On 4/6/16,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL16-076, dated 4/06/16) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. Install Software Version 3.2.3 at their earliest convenience. Foreign affiliates were informed of the issue by e-mail on 4/6/16, and instructed to notify their consignees of the issue and required actions.

Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

34 US Recall 06/06/16

Ortho-Clinical


Rochester NY 14626-

5101

VITROS 3600 Immunodiagnostic System,

Catalog Number 6802783,for use in the in vitro quantitative,

semi-quantitative, and qualitative measurement of a variety of analytes of clinical

interest, using VITROS Immunodiagnostic Products

Reagents.

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

On 4/6/16,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL16-076, dated 4/06/16) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. Install Software Version 3.2.3 at their earliest convenience. Foreign affiliates were informed of the issue by

Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France,

e-mail on 4/6/16, and instructed to notify their consignees of the issue and required actions.

Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

35 US Recall 07/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West


1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35

mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate

with Bending Template. Intended for use in fracture

repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult

populations.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

DePuy Synthes sent an Urgent Medical Device Recall Notice dated May 2, 16, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory immediately and remove the affected lots from their stock. Customers were instructed to call 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product., customers were also asked to complete the Verification Section and scan/email to [email protected]. Customers with questions were instructed to call 610-719-5450.

Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

36 US Recall 07/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West






populations.




37 US Recall 07/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West






populations.




38 US Recall 07/06/16 Medical

ComponentTearaway Introducer, Model # VS203, VS303, 510 K # 130687,

This recall has been initiated due to the product labeled with the incorrect

MedComp sent a Product Recall letter dated May 5, 16 to customers. The letter identified the affected product,

US Distributed to: FL, TX, NC

s, Inc dba MedComp 1499 Delp

Dr Harleysville PA 19438-

2936

packaged individually in a pouch, 5 pouches per carton,

lot # MBZ140, MBZL450, MBZV930 MBZZ490

Product Usage: The 2F and 3F Vascu-Sheath

Tearaway Introducer is intended for percutaneous venous access by modified

Seldinger Technique in neonates, infants and children.

expiration date. problem and actions to be taken. Customers were instructed to evaluate their inventory and quarantine for the return of all un-used affected product. They were asked to contact Customer Service for a Return Goods Authorization (RGA) number at 215-256-9191.

39 US Recall 07/06/16

Berchtold Corp. 1950

Hanahan Rd

Charleston SC 29406-

4878

Surgical Table Cushion (HybriGel Pads)

HybrGel Pads are an optional accessory to the Operon

Surgical Table. The pads may be attached to the base section

with a Velcro fastener. The HybriGel pad shapes and

variants can differ depending on the scope of the delivery.

The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.

Berchtold Corporation sent an Urgent Medical Device Recall letter dated April 19, 16, to all affected customers. The consignees were instructed to return the enclosed acknowledgment form by email to [email protected] and then discard the HybiGel Pads.

Nationwide Distribution

40 US Recall 07/06/16

Remel Inc 12076

Santa Fe Trail Dr

Lenexa KS 66215-3519

Oxoid Nitrocefin (+ Reconstitution Fluid Batch)

REF: SR0112C, Oxoid Ltd. For the rapid chromogenic

detection of beta-lactamase activity in bacterial cells. in

vitro diagnostic

Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.

Customers were notified by letter beginning on March 24, 16. US distribution in MO.

41 US Recall 07/06/16

Apatech Limited

370 Centennial

Ave Elstree United

Kingdom

Actifuse ABX/Actifuse MIS System

A bone void filler intended only for orthopedic applications as a

filler for gaps and voids that are not intrinsic to the stability

of the bony structure.

Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.

The firm, Baxter, sent an "Urgent Product Recall Notification" letter dated 8/18/2015 and a follow-up letter date 4/29/16 to consignees via FedEx, overnight mail. Baxter also notified affected customers by phone. The letters described the product, problem and actions to be take. Baxter Healthcare has instructed customers to do the following: 1. Locate and remove all affected product from their facilities. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. Complete the attached customer reply form and return it to Baxter by either fax it to 224-270-5457 or scanned e-mail to [email protected]. 4. If you distribute this product to other facilities or departments with your institution, notify all

Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland,

affected parties of this communication. For general questions regarding this communication, please call Baxter's Therapeutic Medical Affairs at 805-657-0007 or 862-432-7941.

France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.

42 US Recall 07/06/16

Zimmer Biomet,

Inc. 1800 W

Center St Warsaw IN

46580-2304

Persona Trabecular Metal Tibia; Persona Trabecular

Metal Tibial Plate Instruments and Modular Brackets; Used to

facilitate the implantation of joint replacement implants.

Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.

Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative with the quarantine of any affected product. 3. Zimmer Biomet sales representative will remove the recalled product from customer facilities. 4. Complete the Certificate of Acknowledgement Form and return to: [email protected].

Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.

43 US Recall 07/06/16 Medtronic Neuromod

ulation

Medtronic RestoreSensor, Model 37714; and,

RestoreSensor SureScan, (MRI),

Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge

Consignees were sent on 5/3/16 a Medtronic "Urgent Medical Device Safety notification" letter dated May 16. The letter was addressed to "Healthcare Professional". The letter

Worldwide Distribution

7000

Central Ave Minneapoli

s MN 55421-1241

Model 97714, Implantable Neurostimulators.

Used to treat chronic, intractable pain of the trunk

and/or limbs-including unilateral or bilateral pain.

threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

described the problem and the product involved in the recall. The letter listed the recommendation to patients to follow current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger. Consignees were also requested to complete and return the "Physician Reply Form:. For questions contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7 am - 6 pm CST.

44 US Recall 07/06/16

Hill-Rom, Inc.

1069 State Road 46 E Batesville IN 47006-

7520

Liko Universal SlingBars Universal SlingBar" 350,

Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R,

Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R,

Universal SlingBar" 600 Universal SlingBar" 600 QRH

Component of Liko Lifts Product Usage:

Universal SlingBar 350 It is commonly used for lifting

children. Universal SlingBar 350 is available with three assembly options - fixed

assembly, Quick-release Hook (QRH) or Room 2 Room (R2R).

Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R).

Universal SlingBar 600 It is intended for use with the

ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is

to overlap the leg supports, Universal SlingBar 600 is

The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.

On 3/8/16, MEDICAL DEVICE CORRECTION notifications were sent to the affected US customers via email and courier. On 3/24/16, MEDICAL DEVICE CORRECTION notifications were sent to the affected Canadian customers via email and courier. On 3/29/16, MEDICAL DEVICE CORRECTION notifications were sent to the affected Global customers via email and Docapost. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification provided new instructions for users with a lift manufactured prior to 11/19/2013, instructed the user on how to inspect for damage, and offers replacement at a 50% reduction in cost. If you have any questions concerning this Field Safety Notice, please contact Hill-Rom Technical Support, your distributor, or your Hill-Rom representative.

Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY and ZA.

available with two assembly options - fixed assembly and Quick-release Hook (QRH).

45 US Recall 07/06/16

Greiner Bio-One

North America,

Inc. 4238

Capital Dr Monroe NC

28110-7681

4 ml FX Sodium Fluoride/Potassium Oxalate

tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an

anticoagulant, potassium oxalate. The product is suitable

for the analysis of blood glucose and lactate

The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 16, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.

Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

46 US Recall 08/06/16

GE Healthcare,

LLC 3000 N

Grandview Blvd

Waukesha WI 53188-

1615

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

GE Healthcare sent an " Urgent Medical Device Correction" letter dated May 9, 16, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Detail, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland

Ukraine United Arab Emirates United Kingdom

47 US Recall 08/06/16

GE Healthcare,

LLC 3000 N

Grandview Blvd

Waukesha WI 53188-

1615

Optima 1.5T MR430s MR Scanner, a diagnostic imaging

device

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

GE Healthcare sent an " Urgent Medical Device Correction" letter dated May 9, 16, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Detail, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom

48 US Recall 08/06/16

Brainlab AG Kapellenstr.

12 Feldkirchen

Germany

ExacTrac Vero is a Patient Positioning System for

Radiation therapy.

Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION was sent to customers on May 4, 16 and distributed via email. An active reply by the consignees will be followed, if necessary via further different communication media. As of now for new installations - the Product Notification letter is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a signature

Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium,

is required by the customer that the contained User Corrective Action will be implemented before clinical use by the facility (to be adhered to by the users). Brainlab Instructions and actions required to be performed by the customer are described below. 1. For Positioning and Verification, carefully review plausibility of implant marker fusions resulting in rotation angles of more than 10¿. If in doubt consider the following options before proceeding: - Deselect one or several markers defined in the CT data set, if you suspect these markers to have migrated - Apply bony fusion instead of marker based fusion - Apply ConeBeam CT correction and verification instead of marker based fusion - Acquire a new CT scan and repeat treatment planning and definition of implanted marker positions based on the new CT data. For further details regarding the suggested proceedings, please consult the according Clinical User Guide. 2. For Dynamic Tracking continue to follow the instructions of the Clinical User Guide regarding the review of the correlation model based on implanted marker detections. Specifically: - Examine the correctness of localization of markers and targets in the X-ray sequence. - Verify the consistency of the Target Detection Curve and/or Correlation Model Curve. Irregularities of the curves are an indication for incorrect implanted marker detection. In this case please consider the options described in 1. before proceeding. If the customers require further clarification, they should contact their local Brainlab Customer

France, Germany, Italy, Japan and South Korea.

49 US Recall 08/06/16

Datascope Corporatio

n 15 Law Dr Fairfield NJ

07004-0011

MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion

Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion

Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic

Balloon Catheter with Insertion Kit & STATLOCK¿

MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion

Kit, STATLOCK¿ & APA

It was discovered during post-quarantine packaging on 2/16/16 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/16 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Worldwide Distribution.

50 US Recall 08/06/16 Beckman

Coulter Inc. 250 S

Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following

Beckman Coulter sent an Urgent Medical Device Recall letter dated April 13, 16 to affected customers. The letter identified the affected product, problem and actions to be taken.


Kraemer


System reagent for the quantitative determination of

Uric Acid in human serum, heparinized plasma and urine

on Beckman Coulter AU analyzers.

assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the customer notification letter are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support; (800) 223-0130 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.

including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait,

Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela,

Vietnam, Zambia, and Zimbabwe.

51 US Recall 08/06/16

Beckman Coulter Inc.

250 S Kraemer


Triglyceride, Catalog No. OSR6x118

Product Usage:Triglyceride OSR6x118 is intended as an

Enzymatic colour test for the quantitative determination of triglyceride in human serum

and plasma on Beckman Coulter AU analyzers.

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

Beckman Coulter sent an Urgent Medical Device Recall letter dated April 13, 16 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the customer notification letter are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support; (800) 223-0130 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.

Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India,

Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey,

Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.

52 US Recall 08/06/16


250 S Kraemer


Cholesterol, Catalog No. OSR6x16

Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the

quantitative determination of Cholesterol concentrations in

human serum on Beckman Coulter AU analyzers.



Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar,

Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South

Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.

53 US Recall 08/06/16


250 S Kraemer


Lactate, Catalog No. OSR6x93

Product Usage: Lactate OSR6x93 is intended as

a System reagent for the quantitative determination of

L-Lactate in human plasma and cerebrospinal fluid (CSF) on

Beckman Coulter AU analyzers.



Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador,

Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation,

Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.

54 US Recall 08/06/16


250 S Kraemer


Lipase, Catalog No. OSR6x30 Product Usage:

Lipase OSR6x30 is intended as a System reagent for the

quantitative determination of Lipase activity in human serum

on Beckman Coulter AU analyzers.



Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa

Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru,

Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.

55 US Recall 09/06/16

Stryker Instrument

s Div. of Stryker

Corporation

4100 E Milham

Ave Portage MI

49002-9704

Maestro Air Motor Pneumatic cranial drill motor.

The Maestro Air Pneumatic System is a pneumatically

operated surgical instrument system. The pneumatic motor

provides power to operate removable rotating surgical

cutting tools and their accessories.

Due to the buildup of grease within the hose and motor, there is an increased likelihood that the product may require multiple attempts to start. In addition, there is a possibility that the grease may migrate into the attachment end of the motor. Risk to Health: Although there have been no reported incidents, there is a negligible possibility that the orange grease may leak from the attachme

Stryker sent an "Urgent Medical Device Recall Notification" dated April 28, 16, to all affected customers. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at (269) 389-4518.

Domestic only: AL AR CA FL GA IL IN KS KY MD MI MO NC NM OH OK SC TN TX VA WA WI

56 US Recall 09/06/16 Ellipse A/S Agern Alle

11

Ellipse ND: YAG Laser applicator for Ellipse Nordlys

system

Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

Ellipse A/S has evaluated our instructions in the Service Manual and brought those parts into the Operator's Manual as well which we believe is relevant and usable for the end-

Nationwide Distribution to the states of :

Horsholm Denmark

Medical Laser Products. user of the product. The details in efficiently implementing the distribution of the manual has been evaluated and coordinated with our service provider in the US. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions, please call (760) 798-9550.

NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

57 US Recall 09/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West


Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S

Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to

the stability of the bony structure.

DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.

DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 16, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: [email protected]. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.

Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada.

58 US Recall 09/06/16

Alcon Research,

Ltd. 6201 South

Fwy Fort Worth TX 76134-

2099

CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System

and identified Custom Paks

Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.

The affected consignees were sent a recall notification letter on 4/28/16.

US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia,

Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay

59 US Recall 09/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West







Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT,

WA, WI, WV, WY and Internationally to Canada.

60 US Recall 09/06/16

Ellipse A/S Agern Alle

11 Horsholm Denmark

Ellipse ND: YAG Laser applicator for Ellipse Multiflex

Medical Laser Products.

Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

Ellipse A/S has evaluated our instructions in the Service Manual and brought those parts into the Operator's Manual as well which we believe is relevant and usable for the end-user of the product. The details in efficiently implementing the distribution of the manual has been evaluated and coordinated with our service provider in the US. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions, please call (760) 798-9550.

Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

61 US Recall 09/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West







Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada.

62 US Recall 09/06/16 Becton Henry Schein Single Use BD 10 mL Syringe Luer-Lok Tip with BD Becton Dickinson sent via email and UPS Ground an "Urgent Nationwide

Dickinson &

Company 1 Becton Dr

Franklin Lakes NJ 07417-1815

Syringe Luer-Lock, 10 mL, Intended for use by health care

professionals for general purpose fluid

aspiration/injection

PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use

Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming

manufacturing practices.

Voluntary Product Recall" Letter dated March 25, 16 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.

Distribution to NY only

63 US Recall 09/06/16

Materialise USA LLC 44650

Helm Ct Plymouth MI 48170-

6061

Signature TKA GDE/MDL Set 04-05

Patient-specific surgical guide and instrument set.

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 16. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016

One consignee, Indiana.

64 US Recall 09/06/16

Teleflex Medical

2917 Weck Dr

Research Triangle Park NC 27709-0186

Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube,

Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated.

A tracheal tube is inserted into a patients mouth or nose for

airway management.

The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated May 5, 16 to its accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine product; communicate this recall to any of your customers who have received product; have your customers return to you any affected product with Recall Acknowledgement Form; contact Teleflex Medical Customer Service for more information at 1-866-246-6990; and complete and return Recall Acknowledgment Form via fax to 1-855-419-850, Attn: Customer Service or email to [email protected], even if you and your customers have no affected stock/product. Teleflex will provide you with instructions for the return of product. If you have any other questions, feel free to contact your local sales representative

US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.

or Customer Service at 1-866-246-6990.

65 US Recall 09/06/16

Becton Dickinson &

Company 1 Becton Dr

Franklin Lakes NJ 07417-1815

Henry Schein Single Use Syringe Luer-Lock, 10 mL,

Intended for use by health care professionals for general

purpose fluid aspiration/injection

BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 16 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.

Nationwide Distribution to NY only

66 US Recall 10/06/16

Leica Biosystems Richmond

Inc. 5205 Route

12 Richmond IL 60071

Ariol is an automated scanning microscope and image analysis

system. It is intended for in vitro diagnostic use as an aid to

the pathologist in the detection, classification, and counting of cells of interest based on particular color,

intensity, size, pattern, and shape.

This particular Ariol software application is intended to

measure, count, and quantitate the percentage and intensity of positively stained

nuclei in formalin-fixed paraffin-embedded tissue

specimens immunohistochemically

stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR

results are indicated for use as and aid in the management, prognosis, and prediction of

An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 6, 16. The Medical Device Field Correction letter describes the issues identified with the Ariol Image Analysis and Scanning Systems and the Windows 7 operating system. The letter provided the customer with actions they are required to take which include the following: 1) whether they have a properly activated Windows 7 operating system. 2) If they do not have a properly activated operating system they should to contact Leica Technical Support for additional information and to request a service appointment for correction to their system. For USA customers, they ask that they call 1 800 537 4669. International customers are asked to go to http://www.leicabiosystems.com/contact us/contact us online/ and then choose your country. 3) Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to RichRA@leica microsystems.com or faxing it back to us at 1 847 236 3800. Service personnel will be sent to the affected customer locations to replace the hard drives of the affected

U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.

therapy outcomes of breast

cancer. systems.

67 US Recall 10/06/16

Synthes (USA)

Products LLC

1301 Goshen

Pkwy West


LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-

Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small

bones.

Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.

DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DePuy Synthes Sales Consultant.

Distributed to one customer: Colorado

68 US Recall 10/06/16

Sysmex Corporatio

n 1 5 1

Wakinohamakaigand

oori CHUO-KU Kobe-shi

Japan

The XN-Series modules (XN-10, XN-20) are quantitative multi-

parameter automated hematology analyzers intended

for in vitro diagnostic use in screening patient populations found in clinical laboratories.

There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

Sysmex Corporation sent a Product Notification Field Correction letter were to all affected customers of record. The letters included instructions for customers to: 1) Review results with an unexpected increase in Hgb, MCH, MCHC, and/or PLT-I. The increase may result in a low or normal value being artificially elevated to either a normal result or a result above the reference ranges, or a high value being artificially increased. There is negligble impact to the RBC when the issue occurs; 2) The relationship with an elevated Hgb would cause the indices (MCH and MCHC) values to appear to be abnormally elevated and may result in the results being flagged for verification or indicated to be outside of reference ranges; 3) Review any "Turbidity/Hgb Interf?" flag which will automatically trigger at an MCHC of 37.5 g/dL; 4) If Hgb is affected, the PLT-I may be also. Review any PLT-I result when an unexpected increase in MCH/MCHC or "Turbidity/Hgb Interf?" flag occurs; 5) Gross interference is likely to trigger a flag, however there is a potential any interference could increase the Hgb or the PLT-I count from a lower level to an "normal" level. Follow laboratory protocol for confirming unexpected results. Customers were further advised that they will be contacted by a Sysmex Field Representative within 180 days to schedule an appointment to replace the rinse cup on the analyzer(s) and that version 00-16 software will be installed to change the rinsing sequence for the aspiration probe. Customers with questions are requested to e-mail the Sysmex Technical Assistance Center. Urgent questions can be answered by calling the Technical Assistance Center at 888-879-7639 (24 hours a day / 7 days a week).

Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives,

Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.

69 US Recall 10/06/16

Cordis Corporatio

n 14201 Nw 60th Ave

Miami Lakes FL 33014-2802

Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)

Inability to deploy the stent or partial stent deployment.

Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 16, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship¿ To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted.

NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.

70 US Recall 10/06/16

Cordis Corporatio

n 14201 Nw 60th Ave

Miami Lakes FL 33014-2803

Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

Inability to deploy the stent or partial stent deployment.

Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 16, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship¿ To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714

NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.

71 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd

Parsippany NJ 07054-

3722

TM MONO TIB STR GRN SZ 5 - 00588606510

TM MONO TIB STR GRN SZ 5 12MM - 00588606512







TM MONO TIB STR BLUE SZ 7 10MM - 00588606710








Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/16.

Nationwide and Foreign.

72 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd

REV. SHELL LINER 0D 28X48 00700504828








3723





REV. SHELL LINE 10D 28X66 00701006628









73 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd


3724

TM CR TIB SZ 3 C-H, 10MM- 00588604310

TM CR TIB SZ 3 C-H, 12 mm - 00588604312

TM CR TIB SZ 3 C-H, 14MM - 00588604314

TM CR TIB SZ 3 C-H, 17MM - 00588604317

TM CR TIB SZ 4 C-H 10 MM - 00588604410

TM CR TIB SZ 4 C-H, 12MM - 00588604412

TM CR TIB SZ 4 C-H, 14MM - 00588604414

TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510




TM CR TIB SZ 5 C-H, 12MM -

00588604512 TM CR TIB SZ 5 C-H, 14MM -

00588604514 TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 TM CR TIB SZ 6 C-H, 12MM

00588604612 TM CR TIB SZ 6 C-H, 14 MM

00588604614 TM CR TIB SZ 6 C-H, 17 MM

00588604617 TM CR TIB SZ 7 C-H, 10MM -

00588604710 TM CR TIB SZ 7 C-H, 12MM -

00588604712 TM CR TIB SZ 7 C-H, 14MM -

00588604714 TM CR TIB SZ 7 C-H, 17MM -

00588604717 TM CR TIB SZ 8 C-H, 10MM -

00588604810 TM CR TIB SZ 8 C-H, 12MM -

00588604812 TM CR TIB SZ 8 C-H, 14MM -

00588604814

74 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd


3725

00720504022 ACETAB.CUPW/SH,0DEG,22M

MX40MM 00720504222

ACETAB.CUPW/SH,0DEG,22MMX42MM


MX46MM 00720504828



MX52MM 00720505628




ACETAB.CUPW/SH,0DEG,28M

MX56MM 00720505828



MX60MM 00720506228



MX64MM 00721004222



MX44MM 00721005028



MX52MM 00721005628



MX64MM 00721006628



MX68MM 00721007028


00725504222 ACETAB.CUP, 0

DEG, 22MM X 42MM

00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM




00725505432 ACET CUP, 0 DEG, 32MM X 54MM
















00726004222 ACETAB.CUP,10

DEG, 22MM X 42MM

00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM
















75 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd

Parsippany

POROUS PATELLA 32MM X 10MM - 00587806532

POROUS PATELLA 35MM X 10MM- 00587806535






NJ 07054-

3726

76 US Recall 10/06/16

Zimmer Trabecular

Metal Technology

, Inc. 10

Pomeroy Rd


3727

TM LPS TIB SZ 3 C/D, 10MM - 00588605310

TM LPS TIB SZ 3 C/D, 12MM - 00588605312

TM LPS TIB SZ 3 C/D, 14MM - 00588605314

TM LPS TIB SZ 3 C/D, 17MM - 00588605317

TM LPS TIB SZ 4 C/D, 10MM - 00588605410

TM LPS TIB SZ 4 C/D, 12MM - 00588605412

TM LPS TIB SZ 4 C/D, 14MM - 00588605414

TM LPS TIB SZ 5 E/F 10 MM - 00588605510

TM LPS TIB SZ 5 E/F, 12MM - 00588605512

TM LPS TIB SZ 5 E/F, 14MM - 00588605514

TM LPS TIB SZ 5 E/F, 17MM - 00588605517

TM LPS TIB SZ 6 E/F, 10MM - 00588605610

TM LPS TIB SZ 6 E/F, 12 mm - 00588605612

TM LPS TIB SZ 6 E/F, 17MM - 00588605617

TM LPS TIB SZ 7 G/H, 10MM - 00588605710

TM LPS TIB SZ 7 G/H, 12MM - 00588605712

TM LPS TIB SZ 7 G/H, 14MM - 00588605714

TM LPS TIB SZ 8 G/H, 10MM - 00588605810

TM LPS TIB SZ 8 G/H, 12MM - 00588605812

TM LPS TIB SZ 8 G/H, 14MM - 00588605814




TM LPS TIB SZ 8 G/H, 14MM - 00588605814

TM LPS TIB SZ 8 G/H, 17MM - 00588605817

TM LPS TIB SZ 3 E/F, 10MM - 00588606310

TM LPS TIB SZ 3 E/F, 12MM - 00588606312

TM LPS TIB SZ 3 E/F, 14MM - 00588606314

TM LPS TIB SZ 3 E/F, 17MM - 00588606317

TM LPS TIB SZ 4 E/F, 10MM - 00588606410

TM LPS TIB SZ 4 E/F, 12MM -00588606412

TM LPS TIB SZ 4 E/F, 14MM - 00588606414

77 SA

LEGEND: AUT = Authority MFR = Manufacturer DVC = Device AUS = Australia (TGA) CAN = Canada (Health Canada) US = United States (FDA) SA = Saudi Arabia (SFDA) M = Measure NB: Shaded rows correspond to alerts

JRC105914EUR 28571 ENISBN 978-92-79-68768-6ISSN 1831-9424DOI:10.2760/468483Catalogue number: KJ-NB-28571-EN-N

© European Union, 2017

Documents

Data set compilation of Alerts and Recalls...Data set compilation of Alerts and Recalls Supplementary material of the JRC Technical Report "Exploiting globally available safety information