major safety alerts in may 2008 (this page is subject to further review) · 2018-03-19 · major...

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Major Safety Alerts in May 2008 (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 the summaryof May 2008 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, Canad

MDCO Ref. No. Description of ProductInformation

Source of*

Reference No. bySource

Alert Type by Source Date of (YYYY/MM/DD)

Issue Local Agent Agent ContactTelephone No.

Medtronic Heparin-Coated productsInte

Medtronicrnational Ltd

N/A Firm Initiated Field Action 2008/05/08 Medtronic International,Ltd.

2919 1300

ca

Medical Device Control OfficeDepartment of Health

The Government of HKSAR3Medical Device Control OfficeDepartment of Health

The Government of HKSAR3

al Devnd Health

ice Safety Alerts -April 2008care products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent Agent ContactNo.

SN080401 Smith & Nephew Medullary Exchange Tube (Product Code

Information*

MHRA 2007/004/019/601/816

(YYYY/M

FSCA 2008/04

M/DD) Telephone No

/03 Smith & Nephew Healthcare Ltd. 2648 7700415113, Lot 07AM1186)

SN080402 Varian CT/MR Ring and Tandem Combination App(AL13017000)licator Set

MHRA 2008/003/017/061/004 FSCA 2008/04/03 Varian Medical Systems Pacific Inc. 2724 2836

SN080403 Edwards Lifesciences VAMP Jr MHRA 2008/003/017/061/015 FSCA 2008/04/03 N/A N/A

SN080404 BrainLAB BrainScan MHRA 2008/003/013/061/024 FSCA 2008/04/03 N/A N/A

SN080405 LIFEPAK 20 Defibrillator/monitor FDA Z-1050-2008 Class II 2008/04/03 Medtronic International, Ltd. 2919 1300

SN080406 Terumo Cardiovascular Procedure Kit (P/N 70932-01, 64789-01, FDA Z-1310-2008 to Z-1313-2008 Class II 2008/04/03 Terumo China (H.K.) Ltd. 2866 081170295-02, 70579-04)

SN08040

SN08040

7 Pointe Scientific Liquid Alkaline Phosphatase Reag

8 AMO WHITESTAR SIGNATURE Phacoemulsificat

ent Set

ion System

FDA Z

AMO Asia Limited

-1353-2008 to Z-13

N/A

60-2008 Class II 2008/04

Firm Initiated Field 2008/04

/03 N/A N/A

/07 AMO Asia Limited 2480 3330(NGP680300)

ConMed Linvatec Hall Surgical Blades, Sterile, Single-use,

Action

SN080409 packaged in Bilsters MHRA 2008/003/017/291/001 FSCA 2008/04/08 N/A N/A

SN080410 RITA Starburst XLie Radiofrequency Ablation ProbRadiofrequency Ablation Probee and Talon

MHRA 2008/003/019/061/007 FSCA 2008/04/08 N/A N/A

SN080411 Hospira Butterfly winged needle infusion set MHRA MDA/2008/023 MDA 2008/04/09 Hospira Ltd 2285 8382

SN080412 Skryker ACL Workstation slider (Model Number: 234-010-503) FDA Z-1107-2008 Class II 2008/04/10 Stryker China Ltd 2518 6988

SN080413 Hill-Rom Affinity 4 Birthing Bed (Model P3700B) FDA Z-0617-2008 Class II 2008/04/10 N/A N/A

SN080414 Siemens Mevatron, Oncor, Primus Linear Accelerators FDA Z-1394-2008 to Z-1407-2008 Class II 2008/04/10 Siemens Ltd. 2810 7533

SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled MHRA 2008/003/013/291/008 FSCA 2008/04/10 N/A N/A

SN080416 Stryker Scorpio Knee Femoral Component (Catalo71-5211R, Lot Code: KNAMED, V8WMED)g No. 70-5211R,

MHRA 2008/003/013/291/014 FSCA 2008/04/11 Stryker China Ltd 2518 6988

SN080417 Medivance Instruments Velopex Extra X MHRA 2008/001/003/061/013 FSCA 2008/04/11 N/A N/A

SN080418 Thermogenesis Disposable Processing Set for the5101 AXP System 8-

MHRA 2008/003/012/061/002 FSCA 2008/04/11 N/A N/A

SN080419 Elekta Stereotactic Body Frame CT and MRI indicators MHRA 2008/002/029/601/139 FSCA 2008/04/14 N/A N/A

SN080420 Abbott OPTIUM-H Blood Glucose Test Strips (Lot No. 80111-01)no. 53929/ Part

MHRA 2008/003/025/061/013 FSCA 2008/04/14 Abbott Laboratories Ltd. 2806 4021

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01052.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01052.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01052.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON014736http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON014738http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014701http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014697http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014645




Xcelerant

SN08042

SN08042

1 Arcomedical 3101-TJ (FSB123) Blood Set with Low(Batches C8446)

2 Boston Scientific RX Plastic Biliary Stents

er Y siteMHRA

Boston Scientific

2008/003/013/60

N/A

1/181 FSCA 2008/04

Firm Initiated Field 2008/04

/14 N/A N/A

/15 Boston Scientific Hong Kong Ltd 2960 7128

SN08042

SN08042

3 Boston Scientific Precision Implantable Pluse GeneM365SC11100)

4 Boston Scientific Mach 1 Guide Catheter

rator (UPNHong Kong Ltd

Boston ScientificHong Kong Ltd


N/A

N/A

ActionFirm Initiated Field

Action 2008/04

Firm Initiated FieldAction 2008/04



SN08042

SN08042

5 Boston Scientific Single-Use Rotatable Snares

6 Boston Scientific SteeroCath-Dx and SteeroCath-T

Boston Scientific Epic Over-The-Wire Self-Expand

Catheters

ing Nitinol Stent



Boston Scientific

N/A

N/A



Firm Initiated Field



SN08042

SN08042

7 with Delivery System Stent System

8 Boston Scientific Smash Balloon Dilation Catheter

Hong Kong LtdBoston ScientificHong Kong Ltd

Boston Scientific

N/A

N/A

Action 2008/04





SN08042

SN08043

9 Boston Scientific Various Products

0 Zimmer Hemovac Wound Drainage Device Infection Control Kits

Hong Kong Ltd

FDA Z

N/A

-1448-2008 to Z-1458-2008

Action 2008/04

Class II 2008/04


/17 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SN080431 Medtronic AneuRx AAAdvantage Endovascular SteXcelerant Delivery System Delivery SystemMyelotec Steerable Video Guided Catheter (Produ

nt Graft with the

ct Code 2000

FDA Z-0689-2008 Class II 2008/04/17 Medtronic International, Ltd. 2919 1300

SN08043

SN08043

2and 2010)

3 CES Ultra, Cranial Electrotherapy Stimulator

FDA Z

FDA

-0586-2008 to Z-05

Z-0712-2008

87-2008 Class II 2008/04

Class II 2008/04

/17 N/A N/A

/17 N/A N/A

SN08043

SN08043

4 Ormco Grengloo (Unidose Tips), Bracket adhesiveconditioner (Part Number 740-0322)

5 Nonin Model 2500 PalmSAT handheld pluse Oxim

and tooth

eter

FDA

FDA

Z-0916-2008

Z-0843-2008

Class II 2008/04

Class II 2008/04

/17 L&S Dental Supplies Limited 2815 8115

/17 N/A N/A

SN08043

SN08043

6 Abbott Vascular Xact Rapid Exchange Carotid Ste

7 PROACT Silicone Disposable Armoured LMA SADLA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350

nt System

-LA6320, SAD-

MHRA

MHRA

2008/003/031/29

2007/012/021/40

1/008

1/014

FSCA 2008/04

FSCA 2008/04

/17 Abbott Laboratories Ltd. 2806 4021

/18 N/A N/A

SN08043

SN08043

8 Siemens Medical IMMULITE 2000 CEA kit L2KCEIMMULITE 2500 CEA kit L5KCE2,6 lot 111

9 Huntleigh Healthcare Well-Shin WS-023 power lea

2,6 lot 232 and

d adapters

MHRA

MHRA

2008/002/028/60

MDA/2008/02

1/134

7

FSCA 2008/04

MDA 2008/04

/18 Siemens Ltd. 2810 7533

/18 N/A N/A

SN08044

SN08044

0 Huntleigh Healthcare Birthright birthing bed mattre

1 BHM Medical Maxi Sky 600, V4 and V4i Ceiling Lif

sses

ts

MHRA MDA/2008/02

41375

6 MDA 2008/04

Type II 2008/04

/18 N/A N/A

/21 N/A N/A

SN080442 Smiths Medical BCI 3180 Pulse Oximeter (Model 3180)

Health Canada

Health Canada 41371 Type II 2008/04/22 Goodwin Health Care Holdings Ltd 2408 8838

SN08044

SN08044

3 Biohorizons Implant System Ratchet Extender (Mo

4 Biohorizons Single-Stage Implant System 122-800800)

del # 300-205)

Kit (Model 122-

Health Canada

Health Canada

41433

41374

Type II 2008/04

Type II 2008/04

/22 Specialists' Dental Supplies Limited 9656 7000

/22 Specialists' Dental Supplies Limited 9656 7000

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01053.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01053.htmlhttp://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON014800http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014777http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014771http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014851




SN080445 Elekta PrecisePlan (Model # MRT 7131, MRT 7161) Health Canada 41295 Type II 2008/04/22 N/A N/A

SN080446 Elekta iViewGT Electronical Portal Imaging (Model XRT 1261) Health Canada 41295 Type II 2008/04/22 N/A N/A

SN080447 Somagen IgM HRP ELISA Kit (Model LAPL-K-HRP-001GM, LAPL- Health Canada 41158 Type II 2008/04/22 N/A N/AK-HRP-001M)

SN080448Tornier Aequalis Shoulder (Kelled Glenoid and Cemand Latitude Elbow Prosthesis Cap, Radial Head a

ented Glenoid)nd Ulnar Health Canada 41183 Type II 2008/04/22 N/A N/A

CSN080449 Meridian Bioscience Immunocard Toxins A & B Health Canada 41330 Type II 2008/04/22 N/A N/A

SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103) MHRA 2008/004/003/061/016 FSCA 2008/04/23 N/A N/A

SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E MHRA 2008/002/021/061/018 FSCA 2008/04/23 N/A N/A

SN080452 MEDNET TOPS OUS Fusion System MHRA 2008/001/025/291/005 FSCA 2008/04/23 N/A N/A

SN080453 Medfor S400 and S227 Femoral Head Storage Pot, Labelled, MHRA 2008/002/029/601/140 FSCA 2008/04/23 N/A N/Adouble wrapped

SN080454 Merlin Medical Disposable pen torch (Model no. W2137) MHRA MDA/2008/028 MDA 2008/04/23 N/A N/A

GE Medical Systems Firm Initiated FieldSN080455 GE Healthcare Drytec Tc-99m Generator (all sizes) Hong Kong Ltd. N/A Action 2008/04/24 GE Medical Systems Hong Kong Ltd. 2783 1838

SN080456 Cook Peel-Away Introducer set and Cook TPN Lumen Catheter set FDA Z-0892-2008 to Z-0904-2008 Class II 2008/04/24 Cook Asia (Hong Kong) Ltd. 2781 0232

SN080457 BioRad BioPlex 2200 Instrument FDA Z-0575-2008 Class II 2008/04/24 Bio-Rad Pacific Ltd. 2789 3300

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014090http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014130




Monthly Summary of Medical Device Safety Alerts -March 2008*Note: FD

MDCO Re

A = Food and Drug Administration, United States of A

f.

merica; MHRA = Medicines and Healthcar

Source of

e products Regulatory Agency, United Kingdom; Health Canada

Date of I

= Health Canada, Canada

ssue Agent ContactNo. Description of Product

Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit

Information* Reference No. by Source Alert Type by Source (YYYY/MM/DD) Local Agent Telephone No

SN080301 (CATALOG# IB0900G) Health Canada 40290 Type II 2008/03/03 N/A N/A

SN080302 Zoll Medical E Series Debribillator with 12 Lead ECG Health Canada 40588 Type II 2008/03/03 N/A N/A

SN080303 Stryker Howmedica Modular Replacement System

Walter Lorenz Surgical Pectus Table Top Bender (

, Distal Fem

Trading as:

Health Canada 39226 Type I 2008/03/03 Stryker China Ltd 2518 6988

SN080304 Biomet Microfixation) Health Canada 39755 Type II 2008/03/03 N/A N/A

SN080305 Balt Extrusion Goldbal Detachable Balloons Health Canada 39555 Type II 2008/03/03 N/A N/A

SN080306 Roche Accutrend GC Health Canada 39757 Type II 2008/03/03 Roche Diagnostics (Hong Kong)Limited 2485 7510

SN080307 Stryker Howmedica Trident acetabular shell and Trhemispherical shellident

Health Canada 40619 Type II 2008/03/03 Stryker China Ltd 2518 6988

SN080308 Elekta Precise Plan Health Canada 40747 Type II 2008/03/03 N/A N/A

SN080309 Elekta Precise Treatment Table 40457 Type II 2008/03/03 N/A N/AHealth Canada

SN080310 Elekta Leksell GammaPlan 8.0 Health Canada 40497 Type II 2008/03/03 N/A N/A

SN080311 Abbott Cell Dyn Sapphire Analyzer (model # 08H00-01) Health Canada 40557 Type II 2008/03/03 Abbott Laboratories Ltd. 2806 4021

SN080312 B Braun Aesculap FT420T-FT430T Caspar Aneurysm Clips APP Health Canada 40744 Type I 2008/03/03 B. Braun Medical (HK) Ltd 2277 6611

SN080313 Conmed Endoscopic Ligating Clip Applier (ELC) Health Canada 39961 Type II 2008/03/03 N/A N/A

SN080314 Technidata TD-Synergy V03.11.A Health Canada 40014 Type II 2008/03/03 N/A N/A

SN080315 BD Luer Slip Syringe Products (REF 301294, 301295, 30020) MHRA 2008/002/001/181/009 FSCA 2008/03/05 BD 2518 6988

SN080316 Terumo Weighed Flexible Sucker (Ref Code 804113) MHRA 2008/002/020/061/003 FSCA 2008/03/05 Terumo China (H.K.) Ltd. 2866 0811

SN080317 Trinity Biotech Bartels Viral Respiratory Screening Kit (Prodcut Code B1029-86)and Identification

MHRA 2008/002/021/291/008 FSCA 2008/03/05 N/A N/A

SN080318 WMS Disposable Pen Torch W2137 (Batch Q0140Q01371)3, Q01408,

MHRA 2007/011/006/401/010 FSCA 2008/03/05 N/A N/A

SN080319 Baush and Lomb ReNu Comfort Drops (Lot No 225225757)747 and

MHRA 2008/002/011/061/014 FSCA 2008/03/05 Baush and Lomb 2213 3371

SN080320 Arjo Ambulift Hoist MHRA MDA/2008/010 MDA 2008/03/05 N/A N/A

SN080321 Advanced Bionics Precision Implantable Pluse Gen(Model No. SC-1110)erator Kit

FDA Z-0960-2008 to Z-0961-2008 Class II 2008/03/06 N/A N/A

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01046.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01046.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01046.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014185http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014189http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01047.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01048.html




SN080322 American Medical Systems, Inc., GreenLight HPS (ADDStat) (Part Number: 0010-2090B)Fiber Optic

FDA Z-0131-2008 Class II 2008/03/06 N/A N/A

SN080323 TENET Medical Engineering Wrist Stabilization Kit FDA Z-0577-2008 to Z-0579-2008 Class II 2008/03/06 N/A N/A

SN080324 Orthofix TrueLok External Ring Fixation System, TDistractor (Catalog No. 50-10185)elescopic Linear

FDA Z-0674-2008 Class II 2008/03/06 N/A N/A

SN080325

SN080326

Philips Medical Allura XPER FD10 and FD10/10 w

VNS Therapy Demipulse Generator (103) and Dem

ith AD7

ipulse Duo

MHRA

MHRA

2008/002/021/29

2008/002/021/06

1/001

1/003

FSCA 2008/03

FSCA 2008/03

/12 Philips Electronics Hong Kong Ltd. 2876 7525

/12 N/A N/A

SN080327

Generator (104)Smiths Medical Logical, NovaTrans, and Transtar IPressure Monitoring Kits with Trigger Flush Device

nvasiveMHRA 2008/002/025/291/022 FSCA 2008/03/12 N/A N/A

SN080328 Biomet Vanguard Width Checker (Item Number # 32-487062) MHRA 2008/002/019/061/010 FSCA 2008/03/12 N/A N/A

SN080329 Zimmer Pulsavac Plus Wound Debridement SystemPlus AC Component Kit, Pulsavac Fan Spray Kit a, Pulsavac

nd Hip Kit FDA Z-0856-2008 to Z-0865-2008 Class II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SN080330

SN080331

Stryker Disposable StrykeProbe 32 cm L-Tip and S

Siemens ACUSON Aspen Diagnostic Ultrasound S

patula Tip

ystem (Model

FDA Z

FDA

-0573-2008 to Z-05

Z-0719-2008

74-2008 Class II 2008/03

Class II 2008/03

/19 Stryker China Ltd 2518 6988

/19 Siemens Ltd. 2810 7533

SN080332

Number 8247887)

Zimmer Allofit Shell Size 50 (Model 4244, Lot 2406181) Health Canada 39593 Type II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SN080333 Zimmer Hemovac Infection Control Kits Health Canada 40972 Type II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SN080334 Siemens Syngo Dynamica (Model 100 90 679; Ser93477, 95243, 95248)ial # 92241,

Health Canada 40885 Type II 2008/03/19 Siemens Ltd. 2810 7533

SN080335 Siemens Leonardo Workstation (Model 7129534, Serial # 10413, Health Canada 40580 Type II 2008/03/19 Siemens Ltd. 2810 7533

SN080336

10434, 10599)

Abbott Clinical Chemistry Phenytoin (Model IE07-20) Health Canada 41000 Type II 2008/03/19 Abbott Laboratories Ltd. 2806 4021

SN080337 Siemens Dade Behring Complement Reagents (MLot# 542849)odel OWZD11;

Health Canada 39678 Type II 2008/03/19 Siemens Ltd. 2810 7533

SN080338 Boston Scientific Advanced Bionics Clinician's ProgNavigation V1.02 (Model P/N 9055528-001, SC-71rammer

50) Health Canada 40881 Type II 2008/03/19 Boston Scientific Hong Kong Ltd 2960 7128

SN080339 Draeger Medical Fabius GS (Model# 8604700) Health Canada 40720 Type II 2008/03/19 Draeger Medical Hong Kong Ltd. 2877 3077

SN080340 Beckman Coulter IMMAGE C-Reactive Protein CR(Model # 447280)P Reagent

Health Canada 40898 Type II 2008/03/19 Beckman Coulter Hong Kong Ltd. 2240 6260

SN080341 VIASYS Microjack Patient Interface (Model # GP 3

Cardinal Health Sterile Bowel Resection-Lithotomy

20000-00)

Pack and Major

Health Canada 40966 Type II 2008/03/19 VIASYS Healthcare (Hong Kong) Ltd 6305 5575

SN080342

SN080343

Surgery Packs

Johnson & Johnson, Ortho-Clinical Blood Grouping Reagent Anti-

Health Canada

Health Canada

40924

38920

Type II 2008/03

Type II 2008/03

/19 N/A N/A

/19 Johnson & Johnson Medical Hong 2738 2818Le Bioclone (Model# 715280)

Coopersurgical Mystic II Pump with M-Style Mushrooncup (Model

Kong

SN080344

SN080345

no 10057)

Computerized Medical Systems Focal Workstation

Health Canada

Health Canada

40725

40151

Type II 2008/03

Type II 2008/03

/19 N/A N/A

/19 N/A N/A

SN080346 Allez Spine Size 8 Pedicle Screws (Catalo # LG-PRPR0840, LG-PR0845, LG-PR0850, LG-PR0855, L0835, LG-

G-PR0880) FDA Z-0186-2008 to Z-0191-2008 Class II 2008/03/25 N/A N/A

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01048.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01048.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01048.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01048.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014234http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014330http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014332http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014348http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014371http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014373http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014402http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014407http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON014198http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.html




SN080347 GE Healthcare Mobile Fluoroscopy X-Ray System 7600 AND 7700Linemaster Wireless Footswitch Accessory (Model

OEC Model

SP-9970214-

FDA Z-0716-2008 to Z-0717-2008 Class II 2008/03/25 GE Medical Systems Hong Kong Ltd. 2783 1838

SN080348 005112010 and SP-9970214-005112232) FDA Z-0933-2008 Class II 2008/03/25 N/A N/A

SN080349 Smith & Nephew Exu-Dry Wound Burn Dressing FDA Z-1199-2008 to Z-1217-2008 Class II 2008/03/25 Smith & Nephew Healthcare Ltd. 2648 7700

SN080350Stryker VertePort 10G Access Cannula w/Long StyCement Cannula, 10G Access Canula (short) and

let System, 10G11 G Cement FDA Z-1192-2008 to Z-1195-2008 Class II 2008/03/25 Stryker China Ltd 2518 6988

SN080351

Cannula

Abbott CELL-DYN 1800 System with CELL-DYN 2and the CELL-DYN Calibrators abd CELL-DYN 16

2 Calibrators Controls (Part # FDA Z-0455-2008 Class II 2008/03/25 Abbott Laboratories Ltd. 2806 4021

SN080352

07H77-01)

ALN IVC Filter (Lot: 0107A, 0207A, 0207B, 0307A & 0407A) MHRA 2007/012/012/401/002 FSCA 2008/03/25 N/A N/A

SN080353 GE Heatlhcare Advantx-E, Innova 2000, 2100IQ, 3100/3100IQ MHRA 2008/002/026/061/016 FSCA 2008/03/26 Siemens Ltd. 2810 7533

SN080354

AND 4100/4100IQ

ASTRA PEP/RMT Products (Prodtuct Ref 71001, 71002, 71006,MHRA 2008/002/027/291/003 FSCA 2008/03/26 N/A N/A

SN080355

71007, 71042 and 71052)

Jenx Bee Chair MHRA 2008/002/001/301/001 FSCA 2008/03/26 N/A N/A

SN080356

SN080357

AKW 2000 Series Seats

Olympus AU2700 Clinical Chemistry Analyser (MoSerial: ALL)

dels : ALL;

MHRA

MHRA

2007/009/017/60

2008/003/003/29

1/005

1/003

FSCA 2008/03

FSCA 2008/03

/26 N/A N/A

/26 Olympus Hong Kong Ltd 2376 1805

SN080358 BIO-RAD ScanGel MHRA 2008/003/004/061/009 FSCA 2008/03/26 Bio-Rad Pacific Ltd. 2789 3300

SN080359 Sidhil Millennium Freedom Bed (Product Code(s) 11263/LOW)262, 1263,

MHRA 2007/010/031/061/007 FSCA 2008/03/26 N/A N/A

SN080360 Arcomedical 3100-J (FSB499) Burette Set (Batch N1068) MHRA 2008/003/012/291/012 FSCA 2008/03/26 N/A N/A

SN080361 Trulife Heel & Elbow and the Heel & Ankle Gelbodies MHRA MDA/2008/013 MDA 2008/03/26 N/A N/A

SN080362 Etac Patient Turner (Model 411973300) MHRA MDA/2008/018 MDA 2008/03/26 N/A N/A

SN080363 Medtronic LIFEPAK 1000 MedtronicInternational Ltd N/AFirm Initiated Field

Action 2008/03/26 Medtronic International, Ltd. 2919 1300

SN080364 Cryocath FlexCath Steerable Sheath(Ref 3FC12) CryocathTechnologies Inc. N/AFirm Initiated Field

Action 2008/03/26 Cryocath Technologies Inc. N/A

SN080365 American Medical Systems GreenLight HPS System (Part No. FDA Z-0130-2008 Class II 2008/03/27 N/A N/A

SN080366

0010-0070 and 0010-0075)

Gambro cartridge blood set with Phoenix Hemodialysis System FDA Z-1367-2008 Class II 2008/03/27 Gambro China Ltd 2576 2688

Draeger TI500 Isolette Infant Incubator (Catalog no.: MU20505),SN080367 GT500 Globe Trotter Transport System (Catalog n

and Globe Trotter IC (Catalog no.: MU20509)o.: MU20508) FDA Z-1051-2008 to Z-1053-2008 Class II 2008/03/27 Draeger Medical Hong Kong Ltd. 2877 3077

SN080368 Smith & Nephew CALAXO Bioabsorbable Interference Screw FDA Z-0593-2008 to Z-200806161- Class II 2008/03/27 Smith & Nephew Healthcare Ltd. 2648 7700

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01049.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014415http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014324




SN080369Siemens Magnetom Harmony Mobile MRI System, MagnetomHarmony syngo , Magenetom Symphony Magnetom Sonata syngo FDA Z-1042-2008 to Z-1049-2008 Class II 2008/03/27 Siemens Ltd. 2810 7533and Magnetom Symphony syngo

SN080370 Abbott Clinical Chemistry Creatine Kinase (Model LN 7D63-30) FDA Z-1109-2008 Class II 2008/03/27 Abbott Laboratories Ltd. 2806 4021

SN080371 Stryker Orthopaedics, UHR Universal Bipolar ComProsthesis Componentponent, Hip

FDA Z-0621-208 to Z-0656-2008 Class II 2008/03/27 Stryker China Ltd 2518 6988

SN080372 Stryker Orthopaedics Locking Screw T7 (Catalog n

Ventana Image Analysis Ssystem (VIAS) PATHWA

o 40-27622)

Y anti-HER-

FDA Z-1297-2008 Class II 2008/03/27 Stryker China Ltd 2518 6988

SN080373 2/neu (4B5) primary antibody with software versionno. VIAS-799-10000-00)

2.3.0.2 (Model FDA Z-0571-2008 Class II 2008/03/27 N/A N/A

SN080374 Bausch and Lomb Non-Sterile Multiple-use Phaco needles Bausch and Lomb

Boston Scientific

N/A Firm Initiated FieldAction

2008/03


/27 Baush and Lomb 2213 3371

SN080375 Boston Scientific COGNIS CRT-D device

Osypka Medical External Dual Chamber Pluse Generator PACEHong Kong Ltd N/A Action 2008/03/27 Boston Scientific Hong Kong Ltd 2960 7128

SN080376

SN080377

203H

Volker Nursing Beds (Models 3010 and 5020)

MHRA

MHRA

2008/002/022/40

MDA/2008/02

1/004

0

FSCA 2008/03

MDA 2008/03

/28 N/A N/A

/28 N/A N/A

SN080378 Linet Hospital beds Eleganza Standard, Smart and Deluxe models MHRA MDA/2008/021 MDA 2008/03/28 N/A N/A

SN080379 Smiths Medical CADD-MS 3 Ambulatory Infusion P7400, Recorder No 21-7401-54 and 21-7411-51)ump (Model

MHRA 2008/002/026/291/005 MDA 2008/03/28 Goodman Medical Supplies Ltd 2332 4455

SN080380 Philips Brilliance CT Systems Health Canada 39694 Type II 2008/03/31 Philips Electronics Hong Kong Ltd. 2876 7525

SN080381 Philips Carevue Chart Release C v C.00.00-06 andClinical Info Portfolio D Intellivue

Health Canada 41242 Type II 2008/03/31 Philips Electronics Hong Kong Ltd. 2876 7525

SN080382 Steris Tenzor Carbon Fiber Orthopedic Traction Health Canada 41089 Type II 2008/03/31 Swedish Trading Co., Ltd N/A

SN080383

SN080384

Steris C1160 Tray used with Steris System 1

Steris Amsco Remanufactured Prevacuum Sterilizers

Health Canada

Health Canada

41078

41256

Type II 2008/03

Type II 2008/03

/31 Swedish Trading Co., Ltd N/A

/31 Swedish Trading Co., Ltd N/A

SN080385 Smiths Medical Flo-2 kit With Mask Health Canada 41199 Type II 2008/03/31 N/A N/A

SN080386 Radiometer Medical ABL80'S With Software Version 1.10 Health Canada 38880 Type II 2008/03/31 N/A N/A

SN080387 International Technidyne Corp Avoximeter 1000E Oximeter Health Canada 41136 Type II 2008/03/31 N/A N/A

SN080388 Maquet Jostra Heater-Cooler Unit 30 System Health Canada 41072 Type II 2008/03/31 Maquet Hong Kong Ltd N/A

SN080389 Biosense Webster Navistar RMT Diagnostic/Ablation Catheter Health Canada 41193 Type II 2008/03/31 N/A N/A

SN080390 Popper And Sons Perfektum Toomey Evacuating Syringe Health Canada 40097 Type II 2008/03/31 N/A N/A

SN080391 Tomotherapy Hi-Art System Health Canada 41091 Type II 2008/03/31 TomoKnife (Hong Kong) Ltd 2609 0974

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01041.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033926&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033908&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033905&ssTargetNodeId=967




Monthly Summary of Medical Device Safety Alerts -February 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO ReNo.

f. Description of Product Source ofInformation* Reference No. by Source Alert Type by SourceDate of I

(YYYY/MssueM/DD) Local Agent

Agent ContactTelephone No

SA080201 Organogenesis Apligraf, interactive wound and bur# GS0711.20.01.2A and GS0711.22.01.2A)

Fertility Technology Resources Tucker Embryo Ca

n dressing (Lot

theter and

FDA Z-0675-2008 Class II 01-Feb-08 N/A N/A

SA080202 Morton IUI Catheter FDA Z-0662-2008 to Z-0667-2008 Class II 01-Feb-08 N/A N/A

SA08020

SA08020

3 Hoana LifeBed Patient Vigilance System (Model# 0

4 AADCO Rayshield Frame Mounted Overhead X-R

10135-01)

ay Barrier

FDA

FDA

Z-0592-2008

Z-0552-2008

Class II 01-Feb

Class II 01-Feb

-08 N/A N/A

-08 N/A N/A

SA080205 VNUS 7F ClosureFAST Catheter (Order# CF7-7-6100)0 and CIF7-7-

FDA Z-0542-2008 to Z-0543-2008 Class II 01-Feb-08 N/A N/A

SA080206 Ventana Benchmark, Benchmark XT, Benchmark LT, Discovery FDA Z-0537-2008 to Z-0541-2008 Class II 01-Feb-08 N/A N/Aand Discovery XT Slide Staining System

Intuitive Surgical EndoWrist (Part # 400214-02, 400214-03,SA080207 420214-02 and 420214-03) FDA Z-0258-2008 Class II 01-Feb-08 N/A N/A

SA080208 AmniSure ROM Test (Model # FMRT-1) FDA Z-0120-2008 Class II 01-Feb-08 N/A N/A

SA080209 Biomet Straight Magnum Inserter Handle (REF# orS313141) Catalo #

FDA Z-0115-2008 Class II 01-Feb-08 Goodman Medical Supplies Ltd 2332 4455

SA080210 Johnson and Johnson Depuy TK2 Compression Hip Screw FDA Z-0434-2008 to Z-0435-2008 Class II 01-Feb-08 Johnson & Johnson Medical Hong 2738 2818Trauma Plate (REF 8315-35-004, 8315-35-104) Kong

SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01) FDA Z-0551-2008 Class II 01-Feb-08 Abbott Laboratories Ltd. 2806 4021

SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20) FDA Z-0127-2008 Class II 01-Feb-08 Abbott Laboratories Ltd. 2806 4021

SA080213 Superior Oxy Serve II Oxygen Conserving RegulatMCRB-870-6)or (Model #


SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner Health Canada 40047 Type II 04-Feb-08 Sanko Medical System (HK) Ltd 2384 0688

SA080215 Philips Brilliance Big Bore CT Scanners using softwthrough v2.2.5are v2.2.1

MHRA 2008/001/024/291/004 FSCA 04-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525

SA080216 Abbott AxSYM Drugs of Abuse/Toxicology Assay D(List # 3D54-08)isk Version 8.0

MHRA 2008/001/024/601/003 FSCA 04-Feb-08 Abbott Laboratories Ltd. 2806 4021

SA080217 Stryker Burs MHRA 2008/001/014/291/020 FSCA 04-Feb-08 Stryker China Ltd 2518 6988

SA080218 Siemens Urea Nitrogen (BUN) Flex reagent cartridge (DF21) (Lot MHRA 2008/001/021/601/002 FSCA 04-Feb-08 Siemens Ltd. 2810 7533no. FC8283 and FH8271)

Roche COBAS AmpliPrep/ COBAS Taqman & High Pure Roche Diagnostics (Hong Kong)SA080219 System/COBAS Taqman 48 MHRA 2007/011/019/291/011 FSCA 04-Feb-08 Limited 2485 7510

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01042.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01043.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON013907http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON2033986http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033915&ssTargetNodeId=967




)

SA080220 Corin Cormet Head Trial Size 4/44 MHRA 2008/001/023/291/002 FSCA 04-Feb-08 N/A N/A

SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups Stryker China Ltd N/A Firm Initiated FieldAction 04-Feb-08 Stryker China Ltd 2518 6988

SA080222 Respironics Esprit ventilators CELKI MedicalCompany N/AFirm Initiated Field

Action 06-Feb-08 CELKI Medical Company 2268 9258

SA080223Intuitive Surgical da Vinci S Surgical System 8mm cannula, 8mm Long instrument cannula and 5 mm

instrument instrument FDA Z-0657-2008 to Z-0659-2008 Class II 11-Feb-08 N/A N/A

SA08022

cannula (Part#:420002-01. 420004-01 and 420011

4 Intuitive Surgical da Vinci S Surgical System 5 mm

-01)

instrumentFDA Z-0669-2008 Class II 11-Feb-08 N/A N/Acannula (Part#:420011-01)

Baxter RenalSoft v.2.0 Patient Management Software Suite - HDSA080225 Module and Baxter Renal Software Suite v3.0 and

Link HD Modulev3.1 - Renal FDA Z-0527-2008 to Z-0528-2008 Class II 11-Feb-08 Baxter Healthcare Ltd 2807 8555

SA080226 Philips Gemini 16 and 64-slice PET/CT Systems, Gand 16 slice PET/CT Systemsemini GXL 6, 10

FDA Z-0461-2008 to Z-0462-2008 Class II 11-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525

SA080227 Philips Page Writer Touch Cardiograph (Model # 860284) FDA Z-0124-2008 Class II 11-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525

SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ

Blackstone Hallmark Anterior Cervical Plate System (REF#62-

FDA Z-0690-2008 to Z-0692-2008 Class II 11-Feb-08 GE Medical Systems Hong Kong Ltd. 2783 1838

SA080229 3140) FDA Z-0478-2008 Class II 11-Feb-08 N/A N/A

SA080230 Biomet CC Cruciate Tibial Tray (Product no 141232, 141234) FDA Z-0706-2008 to Z-070-2008 Class II 11-Feb-08 N/A N/A

SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518) FDA Z-0660-2008 Class II 11-Feb-08 N/A N/A

SA080232 Molnycke Health Care Laparoscopic Cholecysectomy MHRA 2008/001/031/291/002 FSCA 12-Feb-08 N/A N/A

SA080233 Schiller FRED Easy Defibrillator MHRA 2008/001/024/291/003 FSCA 12-Feb-08 Ultronics Enterprises Ltd 2764 5208

SA080234 Days Healthcare Viper & Viper Plus Powerchairs MHRA 2008/001/022/301/002 FSCA 13-Feb-08 N/A N/A

SA080235 Arkray Assure 3 Blood Glucose Test Strips (PROD555050)UCT NO


SA080236 Biomet Ringloc Instrumentation Impactor Plate (Re400620 - 31-400623, 31-400626, 31-400628)f/Part # 31-

FDA Z-0700-2008 to Z-0705-2008 Class II 18-Feb-08 Goodman Medical Supplies Ltd 2332 4455

SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1) FDA Z-0934-2008 Class II 18-Feb-08 N/A N/A

SA080238 Horizon Cardiology Hemo Monitoring System FDA Z-0710-2008 Class II 18-Feb-08 N/A N/A

SA080239 Fresenius Medical Care Optiflux 180NR AdvancedPolysulfone (Catalog no. 0500318E) Fresenius

FDA Z-0738-2008 Class II 18-Feb-08 Fresenius Medical Care Asia-PacificLtd. 2802 2900

SA080240 Cook THSCF-35-260-3-AUS2 FDA Z-0135-2008 Class II 18-Feb-08 (1) Cook Asia (Hong Kong) Ltd.; (2)A.R. Burkhill & Sons (Hong Kong) Ltd.(1) 2781 0232; (2)

2541 1041

SA080241 Medtronic Kyphon Functional Anesthetic DiscograpCatheter System (Catlog # D014, D01B)hy (F.A.D.)

FDA Z-0948-2008 to Z-0949-2008 Class II 18-Feb-08 Medtronic International, Ltd. 886-22183-6130

SA080242 Medtronic Cardioblate Gemini-s model 49260 FDA Z-0727-2008 Class II 18-Feb-08 Medtronic International, Ltd. 886-22183-6130

SA080243 Siemens Dade Behring BEP III System MHRA 2008/002/005/061/014 FSCA 20-Feb-08 Siemens Ltd. 2810 7533

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01045.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01045.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014046http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014044http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014007http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014009http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014004http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014011http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON013997




SA080254 Unipath SmartCheck INR POC Meter and Consumables MHRA 2008/002/020/061/008 FSCA 22 Feb 08 N/A N/A

SA08024

SA08024

SA08024

SA08024

4 Care & Independence Systems InChair Sling

5 GE Healthcare InstaTrak 3500 Plus with the CraniaImage Guide Surgery

6 GE Healthcare Clinical Information Centre (CIC) P5.0.6

7 Abbott Comfort T-handle Hudson Connector with Im(Part # 1006-1)

l Application for

ro v5.0.3 and

pactor Cap

MHRA

MHRA

MHRA

FDA

2007/004/030/26

2008/002/011/06

2008/002/006/60

Z-0880-2008

1/002

1/008

1/033

FSCA 20-Feb

FSCA 21-Feb

FSCA 21-Feb

Class II 22-Feb

-08 N/A N/A

-08 GE Medical Systems Hong Kong Ltd. 2783 1838

-08 GE Medical Systems Hong Kong Ltd. 2783 1838

-08 Abbott Laboratories Ltd. 2806 4021

SA08024

SA08024

SA08025

SA08025

8 Siemens Mevatron KD2 Medical Charged-Particle Therapy System

9 Roche LIPC Lipase Colorimetric Reagent (Catalog03029590322)

0 Varian VARiS 1.4g; Linear Accelerator with RTP Ev6.6 and v8.0 (Models : ALL)

1 Hamilton Sample Carriers for the ML STAR line (S(Product Code: 866.2500; Part No. 173400)

Radiation

No.:

xchange v6.2,

MP-CAR-24)

FDA Z

FDA

FDA

FDA

-0677-2008 to Z-06

Z-0688-2008

Z-0718-2008

Z-0718-2008

87-2008 Class II 22-Feb

Class II 22-Feb

Class II 22-Feb

Class II 22-Feb

-08 Siemens Ltd. 2810 7533

-08 Roche Diagnostics (Hong Kong)Limited 2485 7510

-08 Varian Medical Systems Pacific Inc. 2724 2836

-08 N/A N/A

SA08025

SA08025

SA080254

2 Rockwell Medical RenalPure Liquid Acid Concentrand R-259 ; Glacial Acidic Acid and Dri-Sate Glacia

3 ConMed Electrosurgical blades and Needles

Unipath SmartCheck INR POC Meter and Consumables

ate R-006, R-235l Acidic Acid FDA Z

MHRA

MHRA

-0871-2008 to Z-08

2008/002/011/06

2008/002/020/061/008

75-2008

1/011

Class II 22-Feb

FSCA 22-Feb

FSCA 22-Feb

-08 N/A N/A

-08 N/A N/A

-08 N/A N/A

SA08025

SA08025

SA08025

5 Roche Accu-Chek inform Base Unit Serial Number

6 Philips General X-Ray System

7 Philips X-Ray System Types Omni Diagnost Eleva

- UJ33XXXXXX MHRA

MHRA

MHRA

2008/002/006/29

2008/002/012/06

2008/002/013/06

1/001

1/007

1/004

FSCA 22-Feb

FSCA 22-Feb

FSCA 22-Feb

-08 Roche Diagnostics (Hong Kong)Limited 2485 7510

-08 Philips Electronics Hong Kong Ltd. 2876 7525


SA08025

SA08025

8 Chattem Icy Hot Heat Therapy Air Activated Heat apatch - (i) Back; (ii) Arm, Neck, and Leg

9 Philips Easy Diagnost Eleva family, Easy Diagnostand Diagnost 76 plus family

dhesive heating

Classic family

FDA

MHRA

N/A

2008/002/012/061/008

Press Release 26-Feb

FSCA 27-Feb

-08 N/A N/A


SA08026

SA08026

SA08026

SA08026

0 Medtronic Internal Defrillation Handles and Electro

1 Baxa Corporation EM4200 Exacta-Mix CompoundeSoftware V1.05, 1.06 & 1.06.1

2 Bausch and Lomb Stellaris Vision Enhancement S

3 Baxter Heparin Sodium Injection multi-dose, singleHEP-LOCK heparine flush products (lots: ALL)

des

r Operating

ystem

dose vials and

MHRA

MHRA

Bausch and Lomb

FDA

2008/002/015/06

2008/002/014/60

N/A

N/A

1/001

1/063

FSCA 27-Feb

FSCA 27-Feb

Firm Initiated FieldAction 27-Feb

Press Release 29-Feb

-08 Medtronic International, Ltd. 886-22183-6130

-08 N/A N/A

-08 Baush and Lomb 2213 3371

-08 Baxter Healthcare Ltd 2807 8555

SA08026

SA08026

SA08026

4 Siemens Primus Linear Accelerator System and MAccelerator Systems

5 Siemens Syngo Imaging System with VB30A versi(Model No. 10014063)

6 Kodak DirectView Model DR 3000 System, StationSystem

evatron Linear

on of software

ary X-Ray

FDA Z

FDA

FDA

-0850-2008 to Z-08

Z-0732-2008

Z-0731-2008

52-2008 Class II 29-Feb

Class II 29-Feb

Class II 29-Feb

-08 Siemens Ltd. 2810 7533

-08 Siemens Ltd. 2810 7533

-08 Carestream Health Hong Kong Limited 2564 9759

SA08026

SA08026

7 Hill-Rom Avantguard 1200 and 1400 with manuallyout function

8 Hill-Rom Affinity Birthing Bed (Model P3600, P370

operated lock-

0A, P3700B)

MHRA

FDA Z

MDA/2008/00

-0581-2008 to Z-05

8

84-2008

MDA 29-Feb

Class II 29-Feb

-08 N/A N/A

-08 N/A N/A

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01045.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01045.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01045.htmlhttp://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014056http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014059http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014071http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014068http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON014082

Kong

Intuitive Surgical daVinci S Surgical System (Model No. IS2000)SA080269 and Surgical Endoscopic Instrument Control System (Model No FDA Z-0079-2008 Class II 29-Feb-08 Chindex 2892 0301

IS2000)Intuitive Surgical daVinci S Surgical System, Endoscopic

SA080270 Instrument Control System (Model No IS2000) with Isolation FDA Z-0151-2008 to Z-0152-2008 Class II 29-Feb-08 N/A N/ATransformer and Vision Cart (Model VS1000 and VS2000)

Nova EZ CHEM Creatinine Meter, Control Solution and LinearitySA080271 Solution FDA Z-0724-2008 to Z-0726-2008 Class II 29-Feb-08 N/A N/A

SA080272 Philips Digital Diagnost Family MHRA 2008/002/019/063/003 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525

SA080273 Philips EasyVision RAD MHRA 2008/002/020/061/007 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525

SA080274 Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No 2008/002/006/061/001 FSCA 29-Feb-08 Stryker China Ltd 2518 69881320-0231) MHRA

Philips Digital Diagnost family, Bucky Diagnost family, EasySA080275 MHRA 2008/002/019/061/020 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525Diagnost family, Thoravision

SA080276 Depuy polyethylene knee bearings 2007/010/031/061/010 FSCA 29-Feb-08 Johnson & Johnson Medical Hong 2738 2818MHRA




http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01037.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01037.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01037.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01037.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033604&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033624&ssTargetNodeId=967




Mi bi l i P l i D P k I d t C t l # 0691P

Monthly Summary of Medical Device Safety Alerts -January 2008*Note: FD

MDCO Re

A = Food and Drug Administration, United States of A

f.

merica; MHRA = Medicines and Healthcar

Source of

e products Regulatory Agency, United Kingdom; Health Canada

Date of I

= Health Canada, Canada

ssue Agent ContactNo. Description of Product Information* Reference No. by Source Alert Type by Source (YYYY/MM/DD) Local Agent Telephone No

SA080101 Medtronic CD Horizon Agile Dynamic Stabilization

Smiths Medical Graseby 500 and 505 volumetric in

Device

fusion pumps

MHRA 2007/011/013/061/020 FSCA 2008/01/02 Medtronic International, Ltd. 2919 1362

SA080102 (Models: ALL) MHRA MDA/2007/100 MDA 2008/01/02 Smiths Medical (S.E. Asia) Ltd. N/A

SA080103 Medtronic Satellite Spinal System, Satellite SphereSystem Sphere PEEK and Material Stainless Stee CoCr, Satellitel/Radel FDA Z-0192-2008 to Z-0210-2008 Class II 2008/01/03 Medtronic International, Ltd. 2919 1362

Roche Ammonia/Ethanol/CO2 Calibrator, Control N (Normal) and Roche Diagnostics (Hong Kong)SA080104 Control A (Abnormal) (Catalog no. 20751995190, 220753009190)

0752401190, FDA Z-0377-2008 to Z-0379-2008 Class II 2008/01/03 Limited 2485 7510

SA080105 Rita Medical Vortex VX Port System (REF/Part no.Catalog No.: P5455, Latex Free, Sterile): P5455K; FDA Z-0149-2008 Class II 2008/01/03 N/A N/A

SA080106 Ellex Eye Cubed, I 3 System-ABD Ultrasound VersSoftware Version 3.0 and Biometry A-Scan modaliion 3.0 withty FDA Z-0148-2008 Class II 2008/01/03 N/A N/A

SA080107Precept Medical Products Tape Fog Shield SurgicaFiberglass Free and Foam Fog Shield Surgical Ma

l Mask Greensk Green FDA Z-0153-2008 to Z-0154-2008 Class II 2008/01/03 N/A N/A

SA080108

Fiberglass Free (Reorder#65-3322 and 65-3320)Mi bi l i P l i D P k I (P d t Ccro o og cs .vu gar s, uo ac s (Pro uc at l # 0691Pa og , FDA Z-0456-2008 Class II 2008/01/03 N/A N/A

SA080109

ARCC 0427; Exp 2008-9)BatteryZone Life+cel (OEM P/N 9146-001 and 9147L877 and 2L561)

1-001 ; Part # FDA Z-0523-2008 to Z-0524-2008 Class II 2008/01/03 N/A N/A

SA080110 Hill-Rom SM647 Medical Charis and SM608 Relax(Serial no HRP000698167 - HRP000733692)ation Chairs MHRA 2007/012/006/061/016 FSCA 2008/01/07 N/A N/A

SA080111 Philips Digital Diagnost Family

ThermoFisher Scientific DADE Cardiac TL Assayed Cardiac

MHRA 2007/009/006/401/002 FSCA 2008/01/07 Philips Electronics Hong Kong Ltd. 2876 7525

SA080112

SA080113

Marker Control

Horcher Lifting System Powered Patient Positioner

MHRA

MHRA

2007/012/018/05

2007/007/010/40

1/002

1/004

FSCA 2008/01

FSCA 2008/01

/07 N/A N/A

/07 N/A N/A

SA080114 Select Healthcare DUO Transfer Slide Deluxe and Duo Transfer MHRA 2007/008/006/401/005 FSCA 2008/01/07 N/A N/A

SA080115

Slide (Model LOCO-400A and LOCO-410A)Smiths Medical CADD Medication Cassette ReservNo.: 21-7002-24, 21-7001-24, 21-7100-24)

oirs (Recorder MHRA 2007/012/018/051/001 FSCA 2008/01/09 Goodman Medical Supplies Ltd 2332 4455

SA080116 ProTime Microcoagulation System PROTIMEINT MHRA 2007/011/028/291/005 FSCA 2008/01/09 N/A N/A

SA080117 Stryker Distal Depth Screw Guage (Catalog. no. 12146000, MHRA 2007/011/027/061/012 FSCA 2008/01/09 Stryker China Ltd 2518 6988LOT/BATCH NO:K532495)

Stryker Stretchers (Model No.: 660, 721, 735, 1001, 1002, 1005,SA080118 1015, 1020, 1069) MHRA 2007/012/013/061/010 FSCA 2008/01/09 Stryker China Ltd 2518 6988

SA080119 Fresenius Medical Care multiFiltrate acute dialysis

BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Steri

system

le Convenience

MHRA 2007/012/017/051/003 FSCA 2008/01


/09 Fresenius Medical Care Asia PacificLtd.

N/A

SA080120 Paks BD N/A Action 2008/01/09 BD 2575 8668

SA080121 bioMerieux, BacT/ALERT FA Culture Bottles (Lot n101793 and 1017788)o 1017685, FDA Z-0457-2008 Class II 2008/01/11 Biomerieux (Hong Kong) 2356 7033

SA080122 Abbott CELL-DYN Sapphire Hemoglobin Reagent Syringes (List no 08H49-02)Analyzer FDA Z-0301-2008 Class II 2008/01/11 Abbott Laboratories Ltd. 2806 4201

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01039.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01039.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01039.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01039.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01037.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033657&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033670&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033690&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033696&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033700&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033707&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033705&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033726&ssTargetNodeId=967




SA080134 Boston Scientific Galaxy 2 and ClearView Systems N/A 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128

SA080123 Siemens IMMULITE/IMMULITE 1000, IMMULITE 2IMMULITE 2500 Operators000 and MHRA 2008/001/004/601/001 FSCA 2008/01/14 Siemens Ltd. 2810 7533

SA080124 Siemens Syva Emit II Plus Amphetamines Assay (9C039ul, Lot Z10)Catalog No MHRA 2008/001/003/601/002 FSCA 2008/01/14 Siemens Ltd. 2810 7533

SA080125 Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ; MHRA 2007/012/020/061/001 FSCA 2008/01/14 Smith & Nephew Healthcare Ltd.

SA080126

Lot # 20060605)

Fresenius Kabi Orchestra Base Primea MHRA 2008/001/007/061/010 FSCA 2008/01

2645 8703

/14 N/A N/A

SA080127 AMO VISX STAR excimer laser chair MHRA 2008/001/004/061/010 FSCA 2008/01/14 THI Holdings Inc.

SA080128 Stephan Neonatel Transport Ventilator MHRA 2007/012/007/061/002 FSCA 2008/01/15 N/A N/A

SA080129 BD FACSDiva software v6.0 and 6.1 with the HP XComputer SystemW4400 MHRA 2008/001/008/061/012 FSCA 2008/01/15 BD 2575 8668

SA080130 Fannin GU Fibrillator Unit 3821 MHRA 2008/001/009/291/003 FSCA 2008/01/15 N/A N/A

SA080131 Datascope CS 100 Intro-Aortic Balloon Pump and Aortic Balloon PumpCS 300 Intra- MHRA 2008/001/009/291/002 FSCA 2008/01/15 Datascope Corp Asia-Pacific 2647 9713

SA080132 Boston Scientific Stainless Steel Greenfield Vena Cava Filter Boston ScientificHong Kong Ltd N/AFirm Initiated Field

Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128

SA080133 Boston Scientific Slimline 200 Micron Delivery System Boston Scientific N/A Firm Initiated Field 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128Hong Kong Ltd

Boston Scientific

Action

Firm Initiated FieldSA080134 Boston Scientific Galaxy 2 and ClearView Systems

Boston Scientific ICD and CRT-D devices implanted subpectorally

Hong Kong Ltd

Boston Scientific

N/A 2008/01/16Action


Boston Scientific Hong Kong Ltd 2960 7128

SA080135 with the serial number facing the ribs Hong Kong Ltd N/A Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128

SA080136 Siemens Biograph 6, 16, 40-3 Ring, 40 TruePoint, DUO LSO64-3 Ring and FDA Z-0247-2008 to Z-0252-2008 Class II 2008/01/16 Siemens Ltd. 2810 7533

SA080137 Johnson and Johnson CORDIS FireStar and Dura Dilatation CathetersStar RX PTCA Johnson & Johnson

Medical Hong Kong N/AFirm Initiated Field

Action 2008/01/16Johnson & Johnson Medical Hong

Kong 2738 2818

SA080138 Abbott ARCHITECT i System Assay CD-ROM-WW6E59) (List No. (LN) FDA Z-0299-2008 Class II 2008/01/17 Abbott Laboratories Ltd. 2806 4021

SA080139 Ventena Medical System's Symphony Staining Sys(Model # : 2200000; catalog# 900-SYM1 and 900-Stem, KPAYM3) FDA Z-0300-2008 Class II 2008/01/17 N/A N/A

SA080140 Toshiba Aplio XG Diagnostic Ultrasound System (Model: SSA- FDA Z-0305-2008 Class II 2008/01/17 N/A N/A

SA080141

790A with version 1.1 software)

Encore Medical VariLift Bone Plug w/ End Cup FDA Z-0306-2008 to Z-0311-2008 Class II 2008/01/17 N/A N/A

SA080142 Siemens ACUSON Antares, Ultrasound System FDA Z-0297-2008 to Z-0298-2008 Class II 2008/01/17 Siemens Ltd. 2810 7533

SA080143 Oasis Medical PremierEdge MICROSURGICAL KNIFE FDA Z-0485-2008 to Z-0516-2008 Class II 2008/01/17 N/A N/A

SA080144 Fisher and Paykel Healthcare Cosycot UPS MHRA 2007/005/010/401/004 FSCA 2008/01/17 Tokibo Co. (HK) Ltd. 2418 9698

SA080145 Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay MHRA 2008/001/003/291/003 FSCA 2008/01/17 Siemens Ltd. 2810 7533

SA080146

Systems

VacSax and GelSax Disposable Suction Liners MHRA 2007/011/023/401/002 FSCA 2008/01/17 Goodwin Health Care Ltd 2408 8838

Baxter Healthcare Home Choice Automated PD System and HomeSA080147 Choice Pro Automated PD System Health Canada 39272 Type II 2008/01/18 Baxter Healthcare Ltd 2807 8555

SA080148 Baxter Healthcare Infusor 2mL/HR Health Canada 39388 Type II 2008/01/18 Baxter Healthcare Ltd 2807 8555

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033821&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033804&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033774&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01040.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01040.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033736&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033749&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.html




Fi iti d Fi

SA080149

SA080150

SA080151

SA080152

SA080153

BD difco Shigella antiserum poly groupb

BD vacutainer push button blood collection sets wiholder (Model# 367352, 368656)

BD Calibrite APC Beads (Model # 340487)

Philips Medical Allura XPER FD20 System (S/N 29

Philips Medical BV Endura and BV Pulsera (ModelMMC 2011)

th pre-attached

7)

# MMC 2011,

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

39695

39405

39352

39575

39582

Type II 2008/01

Type II 2008/01

Type II 2008/01

Type II 2008/01

Type II 2008/01

/18 BD 2575 8668

/18 BD 2575 8668

/18 BD 2575 8668



SA080154

SA080155

SA080156

SA080157

SA080158

SA080159

Varian RPM Respiratory Gating System

Roche Diagnostics Coagucheck XS PT strips 2x24(Model#4625315017, 4625358017, 4625374190)Bio-Rad Amplicheck Swab CT/GC Control A positi133X)Cardinal Health Medley Pump Module (Model 8100

Henry Schien Mirror Defogger (Model# 1000459, 1

M.C. Healthcare Maxxum Hi/Lo Bed

, 24,6 tests

f (Model # 133,

LVP)

7-20902)

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

39358

39425

39423

39408

39386

39652

Type II 2008/01

Type II 2008/01

Type II 2008/01

Type II 2008/01

Type II 2008/01

Type II 2008/01

/18 Varian Medical Systems Pacific Inc. 2724 2836

/18 Roche Diagnostics (Hong Kong)Limited 2485 7510

/18 Bio-Rad Pacific Ltd. 2789 3300

/18 N/A N/A

/18 N/A N/A

/18 N/A N/A

SA080160

SA080161

SA080162

SA080163

SA080164

BHM Medical 1000LB Scale, 300KG,Class 3 ScaleErgolift with Scale

St. Jude Medical Epic, Atlas and Convert Family of

Smith & Nephew Universal Hip Extractors (Part No

Philips M3170 IntelliVue Patient Link running softwJ.00.23, J.00.24, J.00.25 and J.00.26Abbott CELL-DYN 4000 and CELL-DYN Sapphire (Part A, List # 01H77-01)Datascope Panorama Patient Monitoring Network,

s, 800 LB Scale,

ICDs

. 72200626)

are versions

WBC Reagent

Panorma

Health Canada

St. Jude Medical

MHRA

MHRA

MHRA

39427

N/A

2008/001/004/06

2008/001/011/06

2007/012/024/60

1/003

1/026

1/003

Type II 2008/01

Firm Initiated Fieldrm In ate eldAction 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01

/18 N/A N/A

/18 St. Jude Medical N/A

/21 Smith & Nephew Ltd. N/A



SA080165

SA080166

SA080167

SA080168

SA080169

Telepack 608

Sechrist Hyperbaric Chanmber Curney

Siemens ADVIA Centaur and ADVIA Centaur XP ISystems

Alcon Ophthalmic Procedure Pack

Wescor Osmocoll SS-025, SS-038 and SS-039

Medtronic Synchromed EL, Synchromed II and Iso

mmunoassay

Med drug

FDA

FDA Z

MHRA

MHRA

MHRA

Medtronic

Z-0150-2008

-0733-2008 to Z-07

2008/001/017/29

2008/001/004/06

2008/001/017/29

37-2008

1/012

1/006

1/013

Class II 2008/01

Class II 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01


/24 Datascope Corp Asia-Pacific 2647 9713

/24 N/A N/A

/24 Siemens Ltd. 2810 7533

/24 Alcon Hong Kong Ltd 2568 0636

/24 N/A N/A

SA080170

SA080171

SA080172

SA080173

SA080174

SA080175

SA080176

infusion pumps

ev3 IntraStent Unmounted Balloon Expandable Ste

Chattanooga Electrotherapy Devices (Intelect and

Lombard Medical Aorfix Stent Grafts

Dixons Tudor Edwards Double Rib

Cyberonics VNS Therapy Lead Model 302

BD FACS Sample Prep Assistant II instruments

nts

Vectra Series)

International Ltd

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

N/A

2008/001/011/29

2007/012/020/06

2008/001/017/29

2008/001/017/60

2008/001/002/06

2007/010/002/06

1/003

1/019

1/011

1/001

1/002

1/013

Action 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01

FSCA 2008/01

/24 Medtronic International, Ltd. 2891 4456

/28 Conmed Limited 2854 4413

/28 N/A N/A

/28 N/A N/A

/28 N/A N/A

/28 GM Medical N/A

/28 BD 2575 8668

http://www.fda.gov/cdrh/recalls/recall-122007.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033885&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033891&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033878&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033874&ssTargetNodeId=967

SA080177 Stryker V40 Femoral Heads MHRA 2008/001/016/121/001 FSCA 2008/01/30 Stryker China Ltd 2518 6988

Johnson and Johnson STERRAD Sterilizer System (50, 100S, 200 Johnson & Johnson Medical HongSA080178 MHRA 2007/012/004/061/009 FSCA 2008/01/30 2738 2818and NX Sterilizers) KongMedtronic Model 8870 N'Vision Clinican Programmer SoftwareSA080179 MHRA 2008/001/003/291/014 FSCA 2008/01/30 Medtronic International, Ltd. 2891 4456Application Card

SA080180 Biosite Triage Micro C. Difficile Panel (Catalog no 96000) MHRA 2008/001/017/291/003 FSCA 2008/01/30 N/A N/A

AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and NormalSA080181 FDA N/A Class I/Press Release 2008/01/31 N/A N/ASaline IV Flush Syringes (All Lots and All Sizes)




http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033221&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033264&ssTargetNodeId=967




Monthly Summary of Medical Device Safety Alerts -December 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO ReNo.

f. Description of Product Source ofInformation* Reference No. by Source Alert Type by SourceDate of I

(YYYY/MssueM/DD) Local Agent

Agent ContactTelephone No

SA071201 Medtronic Bravo pH capsule with delivery system (Numbers 9012B1011 and 9012B1001)Proudct Medtronic

International, Ltd. N/AFirm Initiated Field

Action 2007/12/03 Medtronic International, Ltd. 2919 1362

SA071202 Philips Brilliance or MX8000Dual v.EXP CT Couch MHRA 2007/010/029/061/017 FSCA 2007/12/04 Philips Electronics Hong Kong Ltd. 2876 7525

SA071203 Vital PET/CT Visualization option available in ViTAVersion 4.0 and 4.1LConnect MHRA 2007/011/022/061/010 FSCA 2007/12/04 N/A N/A

SA071204

SA071205

ZOLL LifeVest WCD3000 Battery PackDraeger Medical Anaesthetic Gas Scaverging Systreceiver

em (AGSS)MHRA

MHRA

2007/011/026/06

MDA/2007/09

1/018

0

FSCA 2007/12

MDA 2007/12

/04 N/A N/A

/05 Draeger Medical Hong Kong Ltd. 2877 3077

SA071206

SA071207

Procare Privac set (Product code 24760)

Stryker V40+ 16mm Offset Femoral Heads and associated

MHRA

MHRA

MDA/2007/09

2007/011/026/06

1

1/011

MDA 2007/12

FSCA 2007/12

/05 N/A N/A

/06 Stryker China Ltd 2518 6988

SA071208

Femoral Head TrailsBaxter HomeChoice and HomeChoice PRO Automated Peritoneal MHRA 2007/011/030/061/012 FSCA 2007/12/06 Baxter Healthcare Ltd 2807 8555

SA071209

Dialysis SystemOhio Willow Wood Alpha Original Locking Liners (ALL-X0XX / ALL- MHRA 2007/008/013/051/014 FSCA 2007/12/06 N/A N/A

SA071210

X1XX / ALL-X2XX)Steering Developments Lifestyle JW1, JWII and JWPower Assist System

X1 Wheelchair MHRA 2007/006/022/261/001 FSCA 2007/12/06 N/A N/A

SA071211 VIASYS Infant Flow SiPAP Paediatric Respiratory Support Device MHRA MDA/2007/093 MDA 2007/12/07 Viasys Healthcare Hong Kong Ltd 2891 8730

SA071212 MI Tech Hanarostent Anti Reflux and Choostent MHRA 2007/008/014/061/009 FSCA 2007/12/07 N/A N/A

SA071213

SA071214

Sunrise Medical Little Gem 2

Movingpeople.net Beatle Y.e.S.

MHRA

MHRA

2007/011/016/30

2007/005/003/40

1/002

1/001

FSCA 2007/12

FSCA 2007/12

/07 N/A N/A

/07 N/A N/A

SA071215 Philips MD Eleva Flat Detector (Ref XDB087-070515/BW) MHRA 2007/011/030/061/010 FSCA 2007/12/07 Philips Electronics Hong Kong Ltd. 2876 7525

SA071216 Stryker UHR Universal Head Bipolar Component MHRA 2007/011/027/061/002 FSCA 2007/12/07 Stryker China Ltd 2518 6988

SA071217 Terumo Integrated Centrifugal System Control UniLot: 0049, 0079)t (Model 801046, Health Canada 38444 Type II 2007/12/10 Terumo China (H.K.) Ltd. 2866 0811

SA071218

SA071219

Terumo Ultrasonic Air Sensor (Model: 5773, 5785,Philips M3170 Intellivue Patient Link (Model: M317

5791)0, LOT: S/A

Health Canada

Health Canada

39116

38975

Type II 2007/12

Type II 2007/12

/10 Terumo China (H.K.) Ltd. 2866 0811


SA0712204721A01711)Smith & Nephew Genesis II femoral sets Health Canada 39055 Type II 2007/12/10 Smith & Nephew Ltd. 2648 7700

SA071221 Depuy PFC Sigma Knee System - ALL Polyethlen, PS RP Bearing, Health Canada 38472 Type II 2007/12/10 DePuy Inc (J&J)

SA071222

Stabilized TIBI and Preservation Unicondylar KneeAbbott AxSYM Gentamicin and TDx/TDxFLx Genta

-ALL POLmicin (Model Health Canada 38915 Type II 2007/12

2738 2894


SA071223

7A65-20 and 9512-60)Radiometer Pump tubes for ABL800 Series (Model: 842-326, 842- Health Canada 38840 Type II 2007/12/10 N/A N/A

SA071224327, 842-328, 902-754, 905-671)Sigma 8002 Dual Channel Infusion Pump (Model 35061) Health Canada 37977 Type II 2007/12/10 N/A N/A

SA071225 Toshiba Asteion M/S4, Asteion S/S (Mode TSX-021A) Health Canada 38921 Type II 2007/12/10 Sanko Medical System (HK) Ltd 2384 0688

SA071226 Toshiba-Interventional Angiography System, Infinix8000D) i (Model DFP- FDA Z-0293-2008 Class II 2007/12/10 Sanko Medical System (HK) Ltd 2384 0688

http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01033.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01033.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01033.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01033.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01033.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01034.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033416&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033418&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033350&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033369&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033366&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033346&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033315&ssTargetNodeId=967




SA071237 0033080 0033120 0031100 0031070 0033180 0031050 MHRA 2007/010/001/291/003 FSCA 2007/12/14

SA071227 Medtronic 0-arm Imaging System (Product Code B1-700-00027) FDA Z-0294-2008 Class II 2007/12/10 Medtronic International, Ltd. 2919 1362

SA071228 Zimmer Durom Hip Resurfacing Systems, FemoralCode T and 46 Code L (Cat no. 01.00211.154 and Component 54 01.00211.146) FDA Z-0275-2008 to Z-0276-2008 Class II 2007/12/10 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SA071229 Edwards Lifesciences LifeStent FlexStar Bilary SteApplication (Model EX080801CD)nt System FDA Z-0179-2008 Class II 2007/12/10 N/A N/A

SA071230 Teleflex Pilling Center-Action Forceps with Insulated Shafts (Cat FDA Z-0266-2008 to Z-0268-2008 Class II 2007/12/10 N/A N/A

SA071231

no. 505015, 505039 and 505045)Wright Medical Technology Odyssey Femoral Holdno. K001-7410)

er/Driver (Part FDA Z-0290-2008 Class II 2007/12/10 Starry Medical Technology Ltd 2381 0279

SA071232 Xoran MiniCAT for ENT FDA Z-0296-2008 Class II 2007/12/10 N/A N/A

Oridion Capnostream20 Monitor with Nellcor Pulse OximetrySA071233 Module (Part no. CS08657) and Capnostream20 M

Masiomor Pulse Oximetry Module (Part no. CS086onitor with59)

FDA Z-0177-2008 to Z-0178-2008 Class II 2007/12/10 N/A N/A

SA071234 Sunrise Medical Sapphire 2 and Sapphire LS 2 MHRA 2007/010/024/262007/010/009/261/0011/001 FSCA 2007/12/11 N/A N/A

SA071235 Philips Cardiac Viewer and Pulmonary Viewer Application MHRA 2007/011/030/061/009 FSCA 2007/12/12 Philips Electronics Hong Kong Ltd. 2876 7525

SA071236 Henry Schein EasyCam Eurolite, Eurolite II and EuCamerasrodoc Intra-oral MHRA 2007/011/022/601/005 FSCA 2007/12/14 N/A N/A

ConMed Frazier and Poole Suction Intruments (Cat no. 0031030,SA071237 0033080 0033120 0031100 0031070 0033180, , , , , 0031050, MHRA 2007/010/001/291/003 FSCA 2007/12/14 M diMedisource

SA0712380033110, 0035040, 0033100)Roche Elecsys HBsAgII and Elecsys Anti-HBs MHRA 2007/011/008/291/006 FSCA 2007/12/14 Roche Diagnostics (Hong Kong) 2485 7510

Siemens Mevatron M2/PRIMUS Plus, Oncor Impresson Plus.Limited

SA071239 Oncor Impression, ONCOR Avante Garde, MevatrBiomet Orthopedics Vanguard PS Open Femoral (

on M2 PrimusRef. no.:

FDA Z-0380-2008 to Z-0384-2008 Class II 2007/12/14 Siemens Ltd. 2810 7533

SA071240 183130; Lot no. 395450) FDA Z-0123-2008 Class II 2007/12/14 Goodman Medical Supplies Ltd 2332 4455

SA071241

SA071242

Straumann Palatal Implant (Article No. 042.335S a

Frenius Kabi Applix Smart pump (all models)

nd 042.336S) FDA Z

MHRA

-0277-2008 to Z-02

MDA/2007/09

78-2008

8

Class II 2007/12/14 N/A N/A

MDA 2007/12/18 Fresenius Medical Care Asia Pacific

SA071243CME Mckinley MicroSet NDEHP with 1.2 filter and(CME Code: 120-112SFV) (Lot no. 2856-7, 3173-7

SR segment, 3226-7, 3343- MHRA 2007/012/005/061/022 FSCA 2007/12

Ltd

/19 N/A N/A7, 3344-7, 3345-7, 3346-7, 3347-7, 3397-7, 3398-7Sysmex SF-3000 Haematology Analyser, software

) version 00-01SA071244

SA071245on CPSU-4 samplerRadiometer Medical ABL77 Cal Packs

MHRA

MHRA

2007/011/005/40

2007/009/003/06

1/011

1/009

FSCA 2007/12

FSCA 2007/12

/19 N/A N/A

/19 N/A N/A

SA071246 Stryker Hipstar V40 Femoral Stem-127 degrees (C001 - 7850-5-012)at. No. 7850-5- FDA Z-0463-2008 to Z-0474-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988

SA071247 Stryker Hipstar TMZF Cementless Hip Stem Protocol (Product no. FDA Z-0475-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988

SA071248

LSP60)Stryker Triathlon MIS AP Sizer Body-left and RightFemoral Adjustment Block and Triathlon MIS Modu

, Triathlon MISlar Capture FDA Z-0448-2008 to Z-0450-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988

Stryker inTouch Critical Care bed (Model 2130) and StrykerSA071249 inTouch Zoom Critical Care bed (Model 2140) FDA Z-0356-2008 to Z-0357-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988

SA071250

SA071251

B. Braun Excia Cemented Hip Stems (Size 9mm toAbbott ARCHITECT c8000 Processing Module (Lisand ARCHITECT c16000 Processing Module (List

18mm)t no 106-01)no 3L77-01)

FDA Z

FDA

-0436-2008 to Z-04

Z-0146-208 to Z-01

45-2008

47-2008

Class II 2007/12

Class II 2007/12

/20 B. Braun Medical (Hong Kong) Ltd. 2277 6125


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01035.htmlhttp://www.fda.gov/oc/po/firmrecalls/bayer12_07.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033462&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033473&ssTargetNodeId=967http://www.terumo.co.jp/English/press/index.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01038.html




SA071264 Haemonetics cardioPAT FDA 0358 Class II Haemonetics 2868

SA071252

SA071253

SA071254

SA071255

SA071256

SA071257

Roche Diagnostics LightCycler Capillaries (100uL)03337090001, 04391039001, 03603946001, 0353ConMed Accessory Electrode, Universal ElectrodeClean Accessory ElectrodeBD Visitec Nucleus Hydrodissector (Catalog # 585

Accuray Multiplan Treatment Planning Software

Cardinal Health Alaris Pump modules, model 8100modules)Axya Bone Anchor

(Catalog #1414201)s and Ultra

155, 585793)

(Medley Pump

FDA

FDA

FDA Z

FDA

FDA

FDA Z

Z-0459-2008

Z-0452-2008

-0453-2008 to Z-04

Z-0364-2008

Z-0460-2008

-0331-2008 to Z- 03

54-2008

55-2008

Class II 2007/12

Class II 2007/12

Class II 2007/12

Class II 2007/12

Class I 2007/12

Class II 2007/12

/20 Roche Diagnostics (Hong Kong)Limited 2485 7510

/20 N/A N/A

/20 BD 2575 8668

/20 Accuray Asia Ltd 2247 8688

/20 N/A N/A

/21 N/A N/A

SA071258

SA071259

SA071260

SA071261

Mizuho OSI Allegro 6800 Imaging Table (OperatingOperating Room Table 6850

VNUS ClosureFAST catheters (Model no. CL7-7-1

Zimmer Minimally Invasive Solutions Technology OHandles (REF/Catalog# 7712-35-01 and 7712-35-0Blackstone Medical Ascent POCTS (Posterior Occ

) and OSI ProFx

00)

ffset Rasp2)

ipital Cervical

FDA Z

FDA

FDA Z

FDA

-0241-2008 to Z-02

Z-0132-2008

-0316-2008 to Z-03

Z-0363-2008

42-2008

17-2008

Class II 2007/12

Class II 2007/12

Class II 2007/12

Class II 2007/12

/21 N/A N/A

/21 N/A N/A

/21 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

/21 N/A N/A

SA071262

SA071263

SA071264

Thoracic System)ACIST Multi-Use Syringe Kit (Model A2000; SKU#Catalog#800061-003)VKS Tibial Trial, Right/Left, Prep Guide

Haemonetics cardioPAT System (Product list no 02 System (Product list no 02050)

014612,

050)

FDA

FDA

FDA

Z-0359-2008

Z-0362-2008

Z-0358-2008Z 2008

Class II 2007/12

Class II 2007/12

Class II 2007/12 2007/12/21

/21 N/A N/A

/21 N/A N/A

/21 Haemonetics (Hong Kong) Limited 2868 9218 (Hong Kong) Limited 9218

SA071265

SA071266

SA071267

SA071268

SA071269

Single Use Surgical Tibbs cannula - S044 all batch

Liko Sabina II 350-slingbar (prod no. 2027002)

Baxter Infusor 2ml/hr with Tubing Flow Restrictor (2C1071KJP)

OPTI LION E-Plus Cassettes(Model: BP7507)

Cyberonics VNS Therapy Lead (Model 302)

es

Product Code:

MHRA

MHRA

MHRA

MHRA

Cyberonics

Terumo China (H.K.)

2007/011/028/60

2007/011/021/29

2007/012/010/06

2007/011/026/06

N/A

1/002

1/001

1/003

1/019

FSCA 2007/12

FSCA 2007/12

FSCA 2007/12

FSCA 2007/12



/21 N/A N/A

/21 N/A N/A

/21 Baxter Healthcare Ltd 2807 8555

/21 N/A N/A

/21 Cyberonics

SA071270

SA071271

SA071272

Terumo Artifical vascular graft - Triplex

Bayer Contour TS blood glucose test strips

Toshiba Aquilion 32 and Aquilion 64

Ltd.

FDA

Health Canada

N/A

Press Releas

39250

e

Action 2007/12

N/A 2007/12

Type II 2007/12

/21 Terumo China (H.K.) Ltd. 2866 0811

/21 Bayer Healthcare Ltd. (Hong Kong) 2814 7337

/31 Sanko Medical System (HK) Ltd 2384 0688

SA071273

SA071274

TD-Synergy Software (TD-SYN-01)

Instrumentation Laboratory HemosIL RecombiPlasHemoliance RecombiPlasTinBeckman Coulter Cytomics FC 500 Flow Cytomete

Tin and

r and Cytomics

Health Canada

Health Canada

39374

39288

Type II 2007/12

Type II 2007/12

/31 N/A N/A

/31 Beckman Coulter Hong Kong Ltd. 2814 0481

SA071275

SA071276

SA071277

FC 500 MPLBeckman Coulter Cytomics FC 500 Flow Cytomete

Beckman Coulter Sychron CX Systems salicylate r

r

eagent

Health Canada

Health Canada

Health Canada

39286

37157

39284

Type II 2007/12

Type II 2007/12

Type II 2007/12




SA071278Freedom Designs TriPod w/Anti tipper Manual Whno.: TriPod, Tripod LT and TriPod Pediatric LT withTipper-Caster- Axle Link)

eelchair (Model Trailing Anti- FDA Z-0137-2008 Class II 2007/12/31 N/A N/A

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.html

Medtronic Prestige Cervical Disc System, Implant TrialSA071279 (REF/Catalog#: 6972226, 6972246, 6972266, 6972247, 6972267, FDA Z-0138-2008 to Z-0143-2008 Class II 2007/12/31 Medtronic International, Ltd. 2919 1362

6972287)

Gen-Probe Accuprobe Group B Streptococcus CultureSA071280 FDA Z-0145-2008 Class II 2007/12/31 N/A N/AIdentification Test (Catalog.: 2820B and Batch no.: 531379)

SA071281 Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 508- FDA Z-0184-2008 to Z-0185-2008 Class II 2007/12/31 N/A N/A00-036 and 508-00-040)Ellex Solitarie Opthalmic Laser System (Model no : LP4532-DGS

SA071282 P/N303896; Solitaire-SGS P/N 3038960) and Ellex Integre Duo FDA Z-0286-2008 to Z-0287-2008 Class II 2007/12/31 N/A N/A(Model no. LP1RG-S P/N 3040000)

SA071283 OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs FDA Z-0136-2008 Class II 2007/12/31 N/A N/Aand Screw Systems, Distal Screw and Distal PegSA071284 Sultan Brand Mirror Defogger Health Canada 39364 Type II 2007/12/31 N/A N/ASA071285 Hudson Action forceps with insulated shafts Health Canada 38922 Type II 2007/12/31 N/A N/ASA071286 Span-America Medical Systems

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