major safety alerts in february 2011 (this page is subject to … · the following safety alerts...

Date of Issue(YYYY/MM/D

D)Description of Product Source of

Information* Reference No. by Source Alert Type bySource Local Agent Agent Contact

Telephone No.

2011/02/02 IMMUCOR Capture-R® Ready-Id® Extend I MHRA 2011/001/013/081/001 FSCA Uninet Technology LTD 2838 8423

Major Safety Alerts in February 2011 (This page is subject to further review)The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of thesummary of January 2011 and more details will be provided when available

*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;Health Canada = Health Canada, Canada

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON106066�

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Description of Product

Cook Medical Cholangioscopy Access Balloon (DPOC)

Tosoh Europe Automated Enzyme Immunoassay Analyzer (AIA-2000 ST andAIA-2000 LA) Software version below or equal 1.44

William Cook Europe ApS Zilver Flex 35 Vascular Self-Expanding Stent

Roche 1) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 US-IVD, M/N050270121902) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 CE-IVD, M/N04894570190

Varian 4DITC all versions up to and including 8.8.17

Metrax Primedic™ Akupak (M250/M290)

Draeger Infinity ACS Workstation Neonatal Care - Babylog VN500

Cardiac Science GE Responder 2000 Defibrillator / Monitor, models 2025653,2026109, 2026114

Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks

Bio-Rad Laboratories Meridian ANA Screen ELISA Test Kit

BD Beaver-Visitec International (Beaver-Visitec) BD 1% OVD SodiumHyaluronate

Endocare Endocare 2.4mm CRYOPROBE

Ansell Healthcare Products ENCORE (R) Microptic (R) Powder-Free LatexSurgical Gloves

afety Alerts in January 2011 (This page is subje Food and Drug Administration, United States of America; MHRA = Medicines and = Health Canada, Canada

Orthofix Inc Orthofix Bone Marrow Aspiration Needle

Bio-Rad Laboratories Inc Bio-Rad Laboratories Autoimmune EIA ANAScreening kit

CIVCO Body Pro-Lok SBRT System

Fresenius Cabi Injectomat Tiva Agilia

McKesson Medical Imaging Group Horizon Cardiology Hemo

Unomedical Nasogastric feeding tube

Medtronic Model 3093 and 3889 InterStim Tined Leads

Oxoid Legionella Growth Supplement

Walter Lorenz Surgical 1.5 mm Plate

Imris A) Imris OR Table Model T2XB) Imris OR Table Model ORT100

Cincinnati Sub-Zero Temperature Management System

Roche Diagnostics A) Cobas Integra System - AcetaminophenB) Roche Hitachi – Acetaminophen

Siemens A) Mevatron Linear AcceleratorB) Oncor Impression 3D Plus

GE A) Discovery ST16 (Multislice) - Main UnitB) Angioct FP16 SystemC) Discovery SET16 PET/CT Scanner System

Benlan Foley Catheter Tray

Roche Elecsys Anti-Tg

Roche Chemstrip 10A

Ceodeux EZ-OX Plus

Philips IntelliVue Information Center

Beckman Coulter, Inc. Access System - Total BHCG Assay (Model 33500,33505)

Cardinal Health Classic Style Fine Tip Pen with Ruler & Labels (Model250FPRL)

Siemens Medical Solutions A) Acuson Antares System-Main UnitB) Acuson Antares System-Refurbished UnitC) Acuson Antares System-With 5.0 Upgrades

Western/Scott Fetzer Co. EZ-OX Oxygen Regulator (ALQ 1967)

GE Healthcare Signa MR System (various models)

Instrumentation Laboratory Co. ACL Elite; ACL Elite Pro; ACL 9000

Philips Medical Systems (Cleveland), Inc. Brilliance CT System (variousmodels)

BrainLAB Kolibri Spectra Camera Kit

Baxter Healthcare Vial-Mate Adaptor

Depuy Mitek Sterile Intermediary Tube Sets

Elekta• XVI R4.5 Instructions for Use (1010070)• Elekta Synergy® Clinical Mode User Manual for XVI R4.2 (45133702284)• Elekta Synergy® Clinical User Manual for XVI R4.0 (45133702284)• Elekta Synergy® Clinical User Manual for XVI R3.5 (45133702170)• Elekta Synergy� XVI Clinical User & Service Manual (45133702149)

BD FACS 7-Color Setup Beads

Philips Precedence and SKYLight SPECT Systems

Beaver-Visitec Internation (formally BD Medical – Ophthalmic Systems) Visitec® High Viscosity Injectors

Alcon Laboratories Ltd Alcon Custom Ophthalmic Surgical Paks ContainingBeaver-Visitec Visitec® High Viscosity

Biomet Orthopedics A) Comprehensive reverse Shoulder Humeral Tray withLocking Ring (ref. 115350); B) Custom Comprehensive Shoulder Bio-ModularBase (ref. CP561510)

Medtronic Polaris Spectra System Control Unit, StealthStation S7 System

Philips Traxtal PercuNav MP008R-B Button Probe

Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055,3910400060, 3910400065, Soft Eyelet Anchor

Zimmer Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm,non-sterile, REF 9363-32-057

Zoll Model 4000 Monitor component of the LifeVest Wearable Defibrillator.Product number 10A0988-A01

Ev3 The Protege® " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14mm 60mm 80 cm, REF SERB65-14-60-80

Stryker Inion CPS family of products

GE Centricity PACS Web Diagnostic Software Versions: 1.0.0.x

Ortho Europe Aluminium tube clamp Ankle - 6PC574

Siemens ADVIA centaur systems; CA 125 II reagent lot 144

Smith & Nephew Reusable Obturator, Lime Green & Blue, Specific Lots

ArcRoyal Unomedical item 46-25-IDH Bag Urine Night w/lever tap 2L, ArcRoyalRef: 10-006030

Ethicon Omrix Pressure Regulator

Bard LIFESTENT Vascular Stent System

Stanmore Implants, METS Proximal Humeral Component

Stryker Orthopaedics, Triathlon Cemented Tibial Baseplate Size 4

Pride Mobility Products Australia Pty Ltd

B Braun Outlook 400ES Safety Infusion System

Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 and 03-2795-7

GE Medical HiSpeed X/i Computed Tomography operator consoles with theModel Number 2153675 and 2247802

Amstech Inc. Aimshot HeatSeeker Model HS3500

Wyeth Consumer Healthcare ThermaCare Menstrual 8 Hour Heat Wraps

Greiner Bio-One Vacuette 2 ml Lithium Heparin, Collection Tube. Venousblood collection tubes.

Minntech ASP Automatic Endoscope Reprocessor (AER), Product Code:20300 & 20301

Kerr/Pentron Dba Kerr Corporation SDS Kerr Revolution Formula 2 FlowableLight Cure Composite

GE Healthcare HiSpeed LXI, LX/1, DX/I, FX/I

Terumo Air bubble detect module (802110), Occluder module (803480)

Biosense Webster (a JNJ company) CARTO 3 System Interface Cable

Varian Floorstand, an accessory of the Optical Guidance Platform (HZ5)

Cardiac Assist TandemHeart Transseptal Cannulas - EF set (THTC-EF)

Zimmer TiTLE 2 Polyaxial Spinal System

Kreuzer Gmbh & Co/Trumpf Medical Systems klinoPORT, AC poweredOperating Table, Model number: klinoPORT 706, 806, 906, 1006 and 1306

Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, UPNM00550010, UPN M00550020, UPN M00550011 and UPN M00550021

Steris Reliance EPS Endoscope Processing System, Model numbers:MB30001, MB30002, MB30003, MB000077, MB000078, MB000079,MB000080 & MB000081

Encore Medical CLP Instrumentation Removal Hook, distributed by DJOSurgical, Device Listing Number: A776463. Device Part Number: 803-08-033

Sunrise Medical Quickie LXI (EILXI), Manual Wheelchairs with Transit SystemOptionContinental Medical 1) Blood Center Kit w/Chloraprep One-Step2) Port VAD Kit w/Chloraprep One-Step

Stryker Spine Disc Space Distractor

Arrow International Multi Lumen Central Venous Catheterization Set with BlueFlexTip(R) Catheter

Concentric 7F Balloon Guide Catheter

McKesson Medical Imaging Horizon Cardiology ECG Management

Bunnell 1) Life Pulse High Frequency Ventilator, Catalog Number: 203A2) Life Pulse High Frequency Ventilator, Catalog Number: 203

Carl Zeiss VISU 200 on S8 Floor Stand

Dymax Corp Bard CritiCore Monitor, Software Version 2.1

Steris Reliance EPS Endoscope Processing System

CareFusion Alaris GP 150ml Burette Set Model 60103E

ConMed Electrosurgical System 2450 (100V, 120V, 220V & 230V)

Galil Medical Urethral Warmer System Model number FPRCH3001

Ohio Medical Corp Care E Vac 3 Portable Suction

Philips and Neusoft Medical Systems Co., Ltd, China. NeuViz Dual seriesComputed Tomography (CT) Scanner System

Accuray Inc RoboCouch Patient Support System

Bard Access Systems Groshong 3 Fr. Single-Lumen PICC Intermediate Traywith Safety Introducer

Merit Medical Systems One Step Centesis Drainage Catheter

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Pumps

Invacare All powered wheelchairs (including Spectra Plus, HarrierPlus/HD/XHD, Apollo, Mirage)

Convatec Ltd Oxygen Masks and Face Tent Masks

Mölnlycke Health Care Procedure Pak® (Mölnlycke reference: 2307226-00,2310229-00 and 2305239-00)

Harvest Healthcare Xtreme, Graduate, Junior and Stand-Up Hoist Lifts

Intregra LifeSciences LICOX® CMP Tissue Oxygen Monitoring System CatalogNumber AC31-EU

Elekta CMS Software Monaco Release 2.03.00 and Higher (January 2010Forward)

GE Healthcare Xeleris workstation 1.0, 1.1, 2.0, 2.1, 3.0

Elekta CMS Software Software Release 2.03.00 and Higher (January 2010Forward)

Stryker Endoscopy A) IFU for Monopolar CordB) IFU for Bipolar Cable

Codman & ShurtleffA) Codman Disposable Twist DrillB) Codman Metal Disposable ICP Kit, AdultC) Ghajar Guide Ventriculostomy KitD) Codman Cranial Hand Drill

SiemensA) Ethanol 2 AssayB) Ethanol 2 Reagent

Aspen Corneal Marking Pad Sterile

Beckman CoulterA) Coulter Clone & Cyto-Stat/Coulter Clone T11 Monoclonal AntibodyB) Cyto-Stat/Coulter Clone T11-RD1/B1-FITC Monoclonal AntibodyC) Cyto-Stat/Coulter Clone T11-RD1/B4-FITC Monoclonal Antibody

Siemens Verio Magnetom System

DiaSorin ETI-MAX 3000

Covidien Surgipro Mesh, Model no. SPM-35

Bio-Rad Platelia Toxo IgG, Model no. 72840

Olympus Pediatric Resection Electrodes, Model No. A37008A, A37009A,A37010A, A37011A, A37012A, A37013A

Imaging Sciences International Gendex Dental Systems, Expert DC IntraoralX-Ray System with Wall-Mounting Plate, Model No. 110-0207G1 (120 VAC),D800WPEXPERT

Radiometer Medical APS ABL80 FLEX CO-OX System Software 1.30,1.31,Model no. 393-841

Stryker Hydroset Injectable Bone Cement

Siemens Healthcare Diagnostics Inc., Stratus CS Acute Care CardiacTroponin-I Testpack, Model no. CCTNI

Boston Scientific Latitude Patient Management Server Software

Biomet Prosthesis Shoulder - T.E.S.S. Glenoid - Anatomic Insert PE andCementless Baseplate

DePuy Orthopaedic Fixation Plate - Sterile (Model name: Calcaneal X-LargePlate, Distal Tibia Anterolateral Plate, Fibula Anatomic Locking Plate andLocking Distal Tibia Medial Plate)

Visage Imaging Visage 7

DePuy International Ltd Wroblewski Acetabular Cup Trimming Aid SuppliedWith Acetabular Cup Hip Implant

Medico S.p.A Sophos 151, Sophos 155, Helios 300 implantable pacemaker

ThermoFisher Scientific Microbiology Perth Oxoid Ready Poured PlateColumbia Agar with Sheep Blood

Breast Implants

Smiths Medical CADD-Legacy® Duodopa® Pump Software, Revision B or C

Masimo Rad-8 Pulse Oximeter

Merit Medical Systems Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REFNo: PSS-7F-4-038MT, Lot Number: H179575

St Jude Medical MitraXs Atrial Retractor

GE Medical Systems SCS Safesheath® Sealing Adapter Kit With Extension Kit

One Lambda Inc HLA Fusion Software

Source ofInformation* Reference No. by Source Alert Type by

Source Local Agent

Cook Asia Ltd. 1037905 Firm InitiatedField Action Cook Asia Ltd.

MHRA 2010/012/021/081/002 FSCA N.A.

MHRA 2010/012/023/081/003 FSCA A.R. Burkill & Sons(Hong Kong) Ltd.

MHRA 2010/012/021/081/021 FSCA Roche Diagnostics(Hong Kong) Ltd

Varian MedicalSystems Pacific,

Inc.CP-02518 Firm Initiated

Field ActionVarian Medical Systems

Pacific, Inc.

MHRA 2010/012/017/081/015 FSCA Brand Meditech (Asia)Co.,ltd

MHRA 2010/012/023/291/010 FSCA Draeger Medical HongKong Ltd.

FDA Z-0589-2011 Class II Pacific MedicalSystems Limited

FDA N.A. MedWatch N.A.

FDA Z-0613-2011 Class II Bio-Rad Pacific Ltd.

FDA Z-0606-2011 Class II BD

FDA Z-0615-2011 Class II N.A.


ect to further review) Healthcare products Regulatory Agency, United Kingdom;







http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm239148.htm�

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm�





FDA Z-0590-2011 Class III N.A.

FDA Z-0612-2011 Class III Bio-Rad Pacific Ltd.

MHRA 2011/001/004/081/005 FSCA N.A.

MHRA 2010/012/023/081/005 FSCA Fresenius Medical CareHong Kong Limited

MHRA 2010/012/030/081/008 FSCA N.A.

MHRA MDA/2011/003 MDA N.A.

MedtronicInternational Ltd. N.A. Firm Initiated

Field ActionMedtronic International

Ltd.

Health Canada SR0110C Type II N.A.

Health Canada 58413 Type II Swedish Trading Co.,Ltd

Health Canada 59398 Type II N.A.


Health Canada 59845 Type II Roche Diagnostics(Hong Kong) Ltd

Health Canada 59311 Type III Siemens HealthcareDiagnostic Limited

Health Canada 58887 Type III GE Medical SystemsHong Kong Ltd.

Health Canada 59025 Type III N.A.

Health Canada 59326 Type III Roche Diagnostics(Hong Kong) Ltd

Health Canada 59429 Type III Roche Diagnostics(Hong Kong) Ltd






http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON105665?tabName=Device�

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2011-eng.php�











MHRA 2011/001/006/291/016 FSCA Philips Electronic HongKong Ltd

Health Canada 59044 Type II Beckman Coulter HongKong Ltd




Health Canada 56975 Type II GE Medical SystemsHong Kong Ltd.


Health Canada 59355 Type II Philips Electronic HongKong Ltd

Health Canada 59387 Type II BrainLAB Ltd

Health Canada 59460 Type II Baxter Healthcare Ltd

Health Canada 59521 Type II Johnson & Johnson(Hong Kong) Ltd.

MHRA 2011/001/006/291/015 FSCA Elekta Ltd

BD N.A. Firm InitiatedField Action BD

Philips ElectronicHong Kong Ltd FSN88200389, 88200394 Firm Initiated

Field ActionPhilips Electronic Hong

Kong Ltd














MHRA 2011/001/007/081/004 FSCA BD

MHRA 2011/001/010/081/003 FSCA Alcon Hong Kong, Ltd.

FDA Z-0712-2011 to Z-0713-2011 Class II N.A.

FDA Z-0715-2011 Class II Medtronic InternationalLtd.

FDA Z-0617-2011 Class II Philips Electronic HongKong Ltd

FDA Z-0618-2011 Class II Stryker Endoscopy

FDA Z-0619-2011 Class II Zimmer PTE Ltd. (HongKong branch)

FDA Z-0625-2011 Class II Suburfarm Investment& Trading Co., Ltd.

FDA Z-0626-2011 Class II Sinomed Company Ltd.

FDA Z-0630-2011 to Z-0710-2011 Class II Stryker Inion

MHRA 2011/001/011/601/001 FSCA GE Medical SystemsHong Kong Ltd.

MHRA 2010/011/003/401/005 FSCA Ortho Europe Ltd.

MHRA 2010/012/015/601/002 FSCA Siemens HealthcareDiagnostic Limited

Smith & NephewLtd. N.A. Firm Initiated

Field Action Smith & Nephew Ltd.

MHRA 2011/001/013/291/005 FSCA ArcRoyal















MHRA 2009/011/017/401/012 FSCA Johnson & Johnson(Hong Kong) Ltd.

MHRA 2011/001/004/601/004 FSCA Senrex InternationalLtd.

MHRA 2010/010/018/081/012 FSCA N.A.

MHRA 2010/012/021/081/024 FSCA Stryker

TGA N.A. Class II Recall N.A.

FDA Z-0837-2011 Class I B. Braun Medical HongKong

FDA Z-0843-2011 to Z-0844-2011 Class I Fresenius Medical CareHong Kong Limited

FDA Z-0007-2011 Class II GE Medical SystemsHong Kong Ltd.


FDA Z-0622-2011 Class II Pfizer


FDA Z-0628-2011 Class II Schmidt BioMedTech(H.K.) Limited


FDA Z-0744-2011 to Z-0788-2011 Class II GE Medical SystemsHong Kong Ltd.

FDA Z-0882-2011 to Z-0883-2011 Class II TERUMO CHINA (H.K.)LTD.

FDA Z-0884-2011 Class II Johnson & JohnsonMedical (HK)





http://www.tga.gov.au/safety/alerts-device-minicrosser.htm�












FDA Z-0888-2011 Class II Varian Medical SystemsPacific, Inc.


FDA Z-0887-2011 Class II Zimmer PTE Ltd. (HongKong branch)


FDA Z-0809-2011 to Z-0812-2011 Class II Boston Scientific HongKong Ltd

FDA Z-0823-2011 Class II Swedish Trading Co.Ltd.




FDA Z-0895-2011 Class II Stryker China Ltd

FDA Z-0898-2011 Class II Cemma Enterprise Co.,Ltd



FDA Z-0901-2011 and Z-0902-2011 Class II N.A.

FDA Z-0904-2011 Class II Carl Zeiss Far East Co.Ltd



MHRA 2011/001/007/291/008 FSCA CareFusion Hong KongLtd.

MHRA 2011/001/007/081/008 FSCA N.A.
























FDA Z-0846-2011 Class II Philips Electronic HongKong Ltd

FDA Z-0853-2011 Class II Accuray Asia Ltd

FDA Z-0865-2011 Class II Senrex InternationalLtd.

FDA Z-0866-2011 Class II King Health Limited

MedtronicInternational Ltd. N.A. Firm Initiated

Field ActionMedtronic International

Ltd.

MHRA 2008/008/019/301/001 FSCA Direct Health Ltd.

MHRA 2011/001/013/291/006 FSCA N.A.

MHRA 2011/001/018/081/027 FSCA N.A.

MHRA 2010/012/006/291/017 FSCA N.A.

MHRA 2011/001/017/081/014 FSCA N.A.




Health Canada 60178 Type II Stryker China Ltd

Health Canada 59410 Type II Johnson & Johnson(Hong Kong) Ltd.



















Health Canada 59930 Type III Beckman Coulter HongKong Ltd



Health Canada 59843 Type II Tyco Healthcare(HKSAR) Ltd

Health Canada 59953 Type II Bio-Rad Pacific Ltd.

Health Canada 59976 Type II Olympus Hong Kongand China Ltd


Health Canada 60032 Type II Radiometer China(RCHN)

Health Canada 59942 Type II Stryker China Ltd

Health Canada 60053 Type II Siemens HealthcareDiagnostic Limited

MHRA 2011/001/010/081/001 FSCA Boston Scientific HongKong Ltd

MHRA 2010/012/017/081/022 FSCA N.A.


MHRA 2010/012/022/081/014 FSCA N.A.


MHRA 2011/001/010/291/008 FSCA N.A.

















MHRA 2011/001/010/601/001 FSCA N.A.

FDA N.A.News & Events

(PressAnnouncements

)

N.A.

MHRA 2010/009/016/081/019 FSCA Goodman MedicalSupplies Ltd

MHRA 2011/001/025/081/012 FSCA Suburfarm Investment& Trading Co.

FDA Z-0941-2011 Class I King Health Limited

MHRA 2011/001/025/081/027 FSCA St. Jude Medical (HongKong) Ltd.


MHRA 2011/001/024/081/011 FSCA N.A.


http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm�



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96488�




Agent ContactTelephone No.

3472 1688

N.A.

25411041 or22981125

2485 7510

2722 8123

3124 1235

2877 3077

2108 4005

N.A.

2272 8926

2575 8668

N.A.

N.A.

N.A.

2272 8926

N.A.

2583 0813

N.A.

N.A.

2919 1362

N.A.

2953 5111

N.A.

N.A.

2485 7510

2870 7533

2783 1838

N.A.

2485 7510

2485 7510

N.A.

2821 5480

2240 6150

N.A.

2870 7533

N.A.

2783 1838

N.A.

2821 5480

2417 1881

2807 8555

2738 6027

2891 2208

2575 8668

2821 5364

2575 8668

2568 0636

N.A.

2919 1362

2821 5480

2518 6915

2992 0968

2780 9421

2887 7640

2518 6915

2783 1838

N.A.

2870 7533

2648 7700

N.A.

2738 6027

2311 8938

N.A.

2518 6915

N.A.

2529 2009

2583 0813

2783 1838

N.A.

2811 9711

N.A.

2620 8329

N.A.

2783 1838

2866 0811

2738 6027

2722 8123

N.A.

2992 0968

N.A.

2960 7136

6199 0634

N.A.

N.A.

N.A.

2518 6915

2412 2310

N.A.

N.A.

N.A.

2332 0402

N.A.

N.A.

2891 8730

N.A.

N.A.

N.A.

2821 5480

2247 8628

2311 8938

2481 3787

2919 1362

25281109

N.A.

N.A.

N.A.

N.A.

2891 2208

2783 1838/2100 6318

2891 2208

2518 6915

2738 6027

2870 7533

N.A.

2240 6150

2870 7533

N.A.

3157 7220

2272 8926

2170 5678

N.A.

N.A.

2518 6915

2870 7533

2960 7136

N.A.

2738 6027

N.A.

2738 6027

N.A.

N.A.

N.A.

2332 4455

2780 9421

2481 3787

2996 7688

2783 1838

N.A.

major safety alerts in february 2011 (this page is subject to … · the following safety alerts...

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