Monthly Summary of Medical Device Safety Alerts

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Oct 4, 2010 ... Hospira Hospira brand Symbiq One-Channel Infuser LIST No. 16026; Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027. FDA.

Major Safety Alerts in October 2010 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue Source of Alert Type by Reference No. by Source (YYYY/MM/D Description of Product Information* Source D) Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical 2010/10/04 FDA Z-2286-2010 ; Z-2287-2010 Type II Sutures; EP4084N; EP1081P

Local Agent N.A.

2010/10/04

MDC Acquisition ReliaMed Deluxe Portable Adjusting Table

FDA

Z-2288-2010

Type II

N.A.

2010/10/04

3m Imtec 3M Red Dot Monitoring Electrode, Catalog #2560; Novaplus Universal Monitoring Electrode #V2560

FDA

Z-2383-2010

Type II

N.A.

2010/10/04

Roche ONLINE TDM N-acetylprocainamide reagent; Part number 04642520190

FDA

Z-2386-2010

Type II

Roche Diagnostics (Hong Kong) Ltd

2010/10/04

Hospira Hospira brand Symbiq One-Channel Infuser LIST No. 16026; Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027

FDA

Z-2390-2010 ; Z-2391-2010

Type II

Hospira Limited

2010/10/04

Cardinal Medi-Vac Non-Conductive Tubing (with 9 different dimensions)

FDA

Z-2450-2010 thru Z-2458-2010

Type II

Solar-Med Limited

2010/10/04

Philips Medical Systems North America Co. Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x

FDA

Z-2461-2010

Type II

Philips Electronic Hong Kong Ltd

2010/10/04

Philips Medical Systems Philips BV Pulsera Mobile X-Ray system with the extended rotation option; Philips BV Endura Mobile X-Ray system with the extended rotation option

FDA

Z-2463-2010 ; Z-2464-2010

Type II

Philips Electronic Hong Kong Ltd

2010/10/04

TransEnterix Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix. Model number: 9000031

FDA

Z-2465-2010

Type II

N.A.

2010/10/04

Medela Breast pump. Article # 67099S, 67116S, 67093S, and 67094S

FDA

Z-2483-2010 thru Z-2486-2010

Type II

Celki Medical Company

2010/10/04

Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208

FDA

Z-2580-2010 ; Z-2581-2010

Type II

N.A.

2010/10/04

Integra LifeSciences Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only

FDA

Z-2588-2010

Type II

N.A.

2010/10/04

Ventus The Provent Nasal Cannula

FDA

Z-2435-2010

Type II

N.A.

2010/10/04

BD CD10 Apc, CD10 Pe, CD10 Pe-Cy7, CD10 Fitc And Bd Oncomark CD5/CD10/CD19

MHRA

2010/009/014/081/017

FSN

BD

2010/10/04

Rocket Medical Probe - R60547

MHRA

2010/006/022/601/003

FSN

N.A.

2010/10/04

Mountway Smart Charger

MHRA

2010/009/023/301/001

FSN

N.A.

2010/10/04

GE Brightspeed Elite, Brightspeed Excel Select, Brightspeed Edge Select, Brightspeed Elite Select

MHRA

2010/009/027/081/008

FSN

GE Medical Systems Hong Kong Ltd.

2010/10/04

Starion Instruments Corp Starion Instruments Corp - TLS3 35cm Thermal Ligating Shears

MHRA

2010/009/016/081/001

FSN

Ho Yeung Company Ltd

2010/10/04

Spacelabs Healthcare Ultraview Sl2200, Ultraview Sl2400 and Ultraview Sl2600 all with Option-X - 91367-X, 91369-X and 91370-X

MHRA

2010/009/029/291/003

FSN

N.A.

Microm International GmbH

N.A.

Firm Initiated Field Action

Thermo Fisher Scientific (HK) Ltd.

2010/10/04

Thermo Fisher HM550 Cold-Disinfection

2010/10/05

Beckman Coulter Cyto-Stat tetraCHROME reagents - Pn: 6607013 And 6607073

MHRA

2010/009/021/601/004

FSN

Beckman Coulter Hong Kong Ltd

2010/10/05

Joerns Voyager Ceiling Hoist X-Y Gate System

MHRA

2009/010/012/261/001

FSN

N.A.

2010/10/06

Siemens Acuson X300 and X300 PE Diagnostic Ultrasound Systems

MHRA

2010/009/024/051/007

FSN

Siemens Healthcare Diagnostic Limited

2010/10/08

The Helping Hand Standing/Walking Sling, Kloop Sling, Clip Sling, Universal Loop Sling, Anti-Spasm Sling, Hygiene Sling

MHRA

2010/003/018/401/003

FSN

N.A.

2010/10/08

Siemens Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack

FDA

Z-2423-2010

Type II

Siemens Healthcare Diagnostic Limited

2010/10/08

Lab Vision NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit

FDA

Z-2424-2010

Type II

N.A.

2010/10/08

First Quality Hygienic Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons

FDA

Z-2466-2010

Type II

N.A.

2010/10/08

Wright Medical Technology Driver Star #8 Cannulated Dart-Fire (TM), Compression Screw, Size: #8, REF: DSDS-0008, 1 Each, Rx only Non-Sterile

FDA

Z-2470-2010

Type II

Hong Kin Medical Instrument Ltd.

2010/10/08

Biomet, Inc 7,8,9,10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE; 7,8,9,10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE; 8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE

FDA

Z-2597-2010 thru Z-2605-2010

Type II

Swedish Trading Co., Ltd

2010/10/08

Beckman Coulter Access Immunoassay Systems Free T4

FDA

Z-2658-2010

Type II

Beckman Coulter Hong Kong Ltd

2010/10/08

Otech Medical Sarl A) BD2XV, SAGB Quick Close Swedish Adjustable Gastric Band including VelocityTM Injection Port and Applier B) BD3XV, SAGB VC Swedish Adjustable Gastric Band including VelocityTM Injection Port and Applier

Johnson & Johnson Medical (HK) Ltd.

N.A.

Firm Initiated Field Action

Johnson & Johnson Medical (HK) Ltd.

Medtronic International, Ltd.

N.A.

Firm Initiated Field Action

Medtronic International, Ltd.

ConvaTec (Unomedical) Feeding systems and tubes: naso gastric feeding tube with male Luer Lock connectors only. Lot number: 332000

MHRA

2010/010/004/081/016

FSN

N.A.

2010/10/11

Zimmer Nexgen® Complete Knee Solution Legacy® Knee Posterior -Stabilized LPS Components

MHRA

2010/009/024/081/017

FSN

N.A.

2010/10/11

Merck Serono Cortrak

MHRA

2010/009/024/051/002

FSN

Merck Serono Ltd.

2010/10/11

Fresenius Kabi Blood Sampling Device in the Composelect and Compoflex Bloodbag Systems

MHRA

2010/009/023/081/001

FSN

Fresenius Kabi Hong Kong Ltd.

2010/10/11

Ethicon Endo-Surgery (EES) (a J & J Company) Endopath XCEL with OPTIVIEW technology (B12LT, H12LP, D11LT)

Johnson & Johnson Medical (HK) Ltd.

N.A.

Firm Initiated Field Action

Johnson & Johnson Medical (HK) Ltd.

2010/10/11

Allergan Lap-Band® Gastric Band System (LAGB® ); B-200260 & B-20265

Allergan

N.A.

Firm Initiative Field Action

Allergan Asia Limited

2010/10/12

Coloplast Rectal Catheter, Peristeen Anal Irrigation System

MRHA

2009/011/004/081/001

FSN

Coloplast (Hong Kong) Ltd

2010/10/12

Gambro EverFlow Dolphin Protect hemodialysis catheter MC-GDPK-1521, MCGDPK-1525, C-GDPK-1529

MRHA

2010/010/006/081/025

FSN

Gambro Lundia AB

2010/10/12

Biomet Disposable Coring Trephine and Disposable Dowel Harvest Tube

MRHA

2010/007/010/601/001

FSN

Biomet UK Ltd

2010/10/12

BD ProbeTec CT/GC/AC Reagent Pack, Lot no. 0158908, 0158969

BD

N.A.

Firm Initiated Field Action

BD

2010/10/12

Philips Comprehensive Cardiac Analysis (CCA) - Functional Analysis Feature

Philips Electronic Hong Kong Ltd

FSN72800509

Firm Initiated Field Action

Philips Electronic Hong Kong Ltd

2010/10/12

Medtronic Model 5388 Dual-Chamber External Temporary Pulse Generator

Medtronic International, Ltd.

N.A.

Firm Initiated Field Action

Medtronic International, Ltd.

2010/10/13

Systagenix Wound Management Release* Non-Adherent Absorbent Dressing (Lot 1032, 1033, 1034, 1035 and 1036)

MHRA

2010/010/004/081/015

FSN

N.A.

2010/10/13

BD Vacutainer Push Button Collection Set (PBBCS) 23 gauge .75 in x 12 in tubing and luer adapter, specific Lot No.

BD (HK) Ltd.

N.A.

Firm Initiated Field Action

BD

2010/10/08

Medtronic NIM 3.0 Patient Interfaces - All serial numbers

2010/10/11

2010/10/13

CareFusion Alaris PC Unit Model 8015

Health Canada

56561

Type I

CareFusion Hong Kong Ltd.

2010/10/13

CareFusion Alaris PC Unit Model 8000

Health Canada

56581

Type I

CareFusion Hong Kong Ltd.

2010/10/13

Hospira A) Symbiq Microbore Sets, B) Symbiq Pump Burette Set, C) Symbiq Pump Set, D) Hema Primary Symbiq, E) Primary Symbiq Set

Health Canada

56435

Type II

Hospira Limited

2010/10/13

Steris C-Max Surgical Table

Health Canada

56495

Type II

Swedish Trading Co. Ltd.

2010/10/13

Elliquence FT Series Electrodes

Health Canada

56495

Type II

N.A.

2010/10/13

Allied Healthcare CarboLime (Carbon Dioxide Absorbent)

Health Canada

56336

Type II

N.A.

2010/10/13

Gaymar A) Medi-Temp III, B) T-Pump, C) Sof-Care Inflator

Health Canada

56580

Type II

N.A.

2010/10/13

Baxter A) Non-DEHP Y-Type Catheter Extension Sets, B) Clearlink Y-Type Catheter Extension Set, C) Extension Set with Stopcock & Interlink, D) Catheter Extension Set with Luer Valve, E) Micro-Volume Infusion Set with Needle

Health Canada

56586

Type II

Baxter Healthcare Ltd

2010/10/13

GE Web, Pocket And Cellular Viewers

Health Canada

44728

Type II

GE Medical Systems Hong Kong Ltd.

2010/10/13

Beckman Coulter A) Access System-Total T4 Assay, B) UNICEL DXI 600 Access Immunoassay System- Total T4 Assay, C) UNICEL DXI 800 Access Immunoassay System-Total T4 Assay

Health Canada

56619

Type II

Beckman Coulter Hong Kong Ltd

2010/10/13

TriPath Imaging PrepStain

Health Canada

56658

Type II

N.A.

2010/10/13

Siemens EasyLink Informatics system V3 (Model. 100034941)

Health Canada

1/12/2053

Type III

Siemens Healthcare Diagnostics Inc.

2010/10/13

Verathon A) BladderScan BVI 9600 with AortaScan ConsoleB) BladderScan BVM 9500 Console

Health Canada

2/8/2055

Type III

Verathon Inc.

2010/10/13

Biohorizons Single Stage 3.5mm Healing Abutment (Model: SYHA40, Lot. 0903233)

Health Canada

27/9/2054

Type III

Biohorizons Implant Systems, Inc.

2010/10/13

Beckman Coulter AcT 5 Diff Series Hematology Analyzers (Model: 175356, 6605580, 6605641)

Health Canada

14/6/2053

Type III

Beckman Coulter, Inc.

2010/10/14

Lifescan (Johnson & Johnson) One Touch Ultra Test Strips

FDA

Z-2639-2010

Class II

Johnson & Johnson Medical (HK)

2010/10/14

Olympus Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1DF08E

FDA

Z-2642-2010

Class II

Olympus Hong Kong and China Ltd

2010/10/14

Multi-Med Huber needles

FDA

N.A.

Class I

N.A.

2010/10/14

Fresenius proHD set (Product no. 5085901)

Fresenius Medical Care Hong Kong Ltd.

N.A.

Firm Initiated Field Action

Fresenius Medical Care Hong Kong Ltd.

2010/10/15

Hemocue AB Glucose 201 DM Analyzer And Hemocue Hb 201 DM Analyzer

MHRA

2010/010/012/081/010

FSN

Science International Corp.

2010/10/15

BD PrepStain Vacuum Pump (all Schuco and KNF Neuberger models)

BD (HK) Ltd.

N.A.

Firm Initiated Field Action

BD (HK) Ltd.

2010/10/15

Park House Static pressure distribution mattresses

MHRA

2009/011/016/261/004

FSN

N.A.

2010/10/15

Siemens Medical Solutions UK ARTISTE™/ONCOR™/PRIMUS™ Digital Linear Accelerators Model Number 5857912

MHRA

2010/010/004/081/026

FSN

Siemens Healthcare Diagnostic Limited

2010/10/15

Medtronic Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal Segment Revision Kit

MHRA

2010/010/008/291/007

FSN

Medtronic International, Ltd.

2010/10/15

GE Healthcare Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR System

MHRA

2010/010/008/081/008

FSN

GE Medical Systems Hong Kong Ltd.

2010/10/18

BD Needle 24G 1IN TW VIOLET NS Syringe 3ml LL 23G 1IN TW Syringe 3ml LS 24G 1IN TW Syringe 1ml LS 27G 1/2IN ID Syringe 1ml LS 28G 1/2IN ID

BD

N.A.

Firm Initiated Field Action

BD

Varian Medical Systems Pacific Inc.

CP-02327 / CTB-694

Firm Initiated Field Action

Varian Medical Systems Pacific Inc.

2010/10/18

Varian FastPlan SRS Treatment Planning Systems

2010/10/18

Olympus Endoscope Washer Disinfector - Olympus Etd3 Plus

MHRA

2010/009/027/081/014

FSN

Olympus Hong Kong and China Ltd

2010/10/18

Roche Diagnostics Accu-Chek Multiclix in Accu-Chek Aviva Expert Kits

MHRA

2010/009/030/291/015

FSN

Roche Diagnostics (Hong Kong) Ltd

2010/10/18

Smiths Medical Level 1® Normothermic I.V. Fluid Administration Sets, Product Codes D-60 HL and DI-60HL

MHRA

2010/010/007/081/022

FSN

N.A.

2010/10/21

Leica Microsystems Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1

FDA

Z-2497-2010 thru Z-2499-2010

Class II

Leica Microsystems Limited

2010/10/21

Linvatec GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only

FDA

Z-2503-2010

Class II

N.A.

2010/10/21

Biomet 1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600; 2) Modular Microplasty Cup impactor 1/4" - 28 thread insert, REF 31-400605.

FDA

Z-2504-2010, Z-2505-2010

Class II

N.A.

2010/10/21

ConvaTec (Unomedical) Engenex Non Acute Care Suction Cup for use with Engenex Negative Pressure Wound Therapy.

FDA

Z-2609-2010

Class II

N.A.

2010/10/21

Covidien AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code: 6066; Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code: 6067.

FDA

Z-2656-2010, Z-2657-2010

Class II

Covidien

2010/10/21

Inverness 1) UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy. 2) UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.

FDA

Z-2500-2010, Z-2501-2010

Class III

N.A.

2010/10/21

Spacelabs Healthcare TruLink Pre-wired Neonate ECG Electrodes PN:6850037-00 (Lot. 0904014-1007064)

MHRA

2010/010/015/081/019

FSN

Spacelabs Healthcare Inc.

2010/10/21

Trumpf Orbiter patient transfer system

MHRA

2010/009/008/081/010

FSN

Trumpf Medizin Systeme GmbH

2010/10/21

Siemens Healthcare Diagnostics Immulite 2500 HCG

MHRA

2010/009/028/291/008

FSN

N.A.

2010/10/21

GBUK Healthcare Suction Catheter TT03-14-T34-N

MHRA

2010/010/004/601/002

FSN

N.A.

2010/10/21

Siemens 4Z1c matrix array transducers on the Acuson SC2000™ volume imaging ultrasound system

MHRA

2010/010/006/081/021

FSN

N.A.

2010/10/21

Spacelabs Healthcare Inc. WA Elance Vital Signs Monitor, model 93300

MHRA

2010/010/015/081/018

FSN

Schmidt BioMedTech (H.K.)

2010/10/21

Stryker Universal Flat Panel Yoke

MHRA

2010/010/012/081/004

FSN

Stryker China Ltd

2010/10/22

BioMerieux Immuno VIDAS HIV DUO QUICK

bioMerieux China Ltd.

N.A.

Firm Initiated Field Action

bioMerieux China Ltd.

2010/10/22

GE Healthcare OEC 9800 C-Arm and OEC 9900 C-Arm

MHRA

2010/010/013/081/012

FSN

GE Medical Systems Hong Kong Ltd.

2010/10/22

Boston Scientifc Expect Enscopic Ultrasound Aspiration Needle

Boston Scientific Hong Kong Ltd

N.A.

Firm Initiated Field Action

Boston Scientific Hong Kong Ltd

2010/10/22

Philips Allura Xper Systems and Allura Integris Systems Multi Diagnost Eleva and Omni Diagnost Eleva Systems

Philips Electronic Hong Kong Ltd

XCR603-100324

Firm Initiated Field Action

Philips Electronic Hong Kong Ltd

2010/10/22

Boston Scientific Matrix 2 Detachable Coil

Boston Scientific Hong Kong Ltd

N.A.

Firm Initiated Field Action

Boston Scientific Hong Kong Ltd

2010/10/25

Elekta XIO Radiation Treatment Planning System (Release 4.2.0 and higher )

Health Canada

56660

Type II

Elekta Ltd

2010/10/25

Bio-Rad IN2IT (I) A1C Test Cartridges, Kit 072T100 / Cartridge 39088

Health Canada

56751

Type II

Bio-Rad Pacific Ltd.

2010/10/25

Dental Equipment Dental Chair Magnetic Headrest Assembly

Health Canada

53872

Type II

N.A.

2010/10/25

Zimmer A) Bigliani/Flatow Shoulder IM Reamers B) TM Shoulder Instrument Distal Pilot

Health Canada

56687

Type II

Zimmer PTE Ltd. (Hong Kong branch)

2010/10/25

American Medical Systems Advance Male Sling System

Health Canada

56924

Type II

N.A.

2010/10/25

Elekta XIO Radiation Treatment Planning System Release 4.3.0 & Higher

Health Canada

56972

Type II

Elekta Ltd

2010/10/25

Welch Allyn PIC 50

Health Canada

56795

Type II

N.A.

2010/10/25

Philips Essenta DR Compact

Health Canada

56346

Type II

Philips Electronic Hong Kong Ltd

2010/10/25

Medline Industries Evacuator Kit with Drain and Trocar

Health Canada

56615

Type II

N.A.

2010/10/25

Beckman Coluter A) UniCel DxC 600 and UniCel DxC 600 PRO B) UniCel DxC 800 and UniCel DxC 800 PRO C) UniCel DxC 600I Synchron Access Clinical Analyzer D) UniCel DxC 880I Synchron Access Clinical Analyzer E) Synchron LXI 725 F) Synchron LX20 Pro G) UniCel DxC 660i Synchron Access Clinical Analyzer H) UniCel DxC 600i Synchron Access Clinical Analyzer I) UniCel DxC 860i Synchron Access Clinical Analyzer

Health Canada

56657

Type II

Beckman Coulter Hong Kong Ltd

2010/10/25

Linvatec Corporation D.B.A. Conmed Linvatec Arthroscopy Outflow/Suction Tubing Set (Model: 24K100, Lot: 22747-000, 22749-000)

Health Canada

56697

Type II

N.A.

2010/10/25

Beckman Coulter A) Synchron CX5, CX5 Delta and CX5 CE Clinical Systems (Model: 448700, 468243, 759300) B) Synchron CX4, CX4 Delta and CX4 CE Clinical Systems (Model: 468233, 756600) C) Synchron CX7 and CX7 Delta Clinical Systems (Model: 468205, 756601) D) Synchron CX9 ALX Clinical System (Model: 473513)

Health Canada

56656

Type II

Beckman Coulter Hong Kong Ltd

2010/10/25

Sybron Microseal Master Cones, Model no.: 815-9033

Health Canada

56894

Type III

N.A.

2010/10/25

Lab Vision Lab Vision Autostainer

Health Canada

56938

Type III

N.A.

2010/10/25

Sybron RealSeal Accessory Points

Health Canada

56974

Type III

N.A.

2010/10/25

Verathon ScanPoint Communication Cradle

Health Canada

56806

Type III

Verathon Inc.

2010/10/25

Becton Dickinson PrecisionGlide needle 30 gauge

Health Canada

56442

Type III

Becton Dickinson Asia Ltd.

2010/10/25

TOSOH BIOSCIENCE LTD Tosoh AIA-PACK B12

MHRA

2009/001/014/401/008

FSN

N.A.

2010/10/25

DiaMed GmbH Diaplastin-E Liquid

MHRA

2010/009/021/081/026

FSN

N.A.

2010/10/25

Stryker Scorpio Fixed Femoral AP Sizing Guide, Scorpio Sizing Guides (Catalog no.: 8000-0313, 8001-0313, Limited to lots beginning with the letters “RD”)

MHRA

2010/010/012/081/018

FSN

Stryker Europe, Middle East & Africa

2010/10/25

Philips CS X-ray Ceiling Suspension

MHRA

2010/009/029/291/013

FSN

Philips Healthcare

2010/10/25

MIS Digital image processing unit

MHRA

2010/006/010/401/012

FSN

MIS Healthcare Ltd, EcomTechnology Limited

2010/10/25

Novalung Vision Alpha Ventilator / Metran R 100 (Vision Alphas with Serial Numbers 139 to 159)

MHRA

2010/009/024/081/012

FSN

Novalung GmbH

2010/10/25

AngioDynamics Habib 4x Kit Bipolar Resection Device

MHRA

2010/009/027/081/005

FSN

AngioDynamics UK Ltd

2010/10/25

MDSS Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712, Lot # MV0146 Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713, Lot # MC0146 Cholestech LDCX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10982, Lot # SV0146 Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983, Lot # SC0146 Cholestech LDX Calibration Verification, Levels 1 - 4, Catalog Number 11-255, Lot # 0146

2010/10/25

MHRA

2010/010/011/081/006

FSN

MDSS (Medical Device Safety Service) GmbH, Alere, Inc.

Medtronic Sprint Quatrro Secure S 6935 and Sprint Quattro Secure 6947

Medtronic International, Ltd.

N.A.

Firm Initiated Field Action

Medtronic International, Ltd.

2010/10/26

Varian Exact Couch for Clinac or Acuity (Trapping Zones)

Varian Medical Systems Pacific Inc.

CP-02427E

Firm Initiated Field Action

Varian Medical Systems Pacific Inc.

2010/10/26

Karl Storz Endoscopy UK Ltd AIDA Compact II Image Capture System (Software v 2.4)

MHRA

2010/002/015/081/010

FSN

KARL STORZ Endoscopy China Ltd.

2010/10/27

Völker-Healthcare Beds 2080, 3010, 3080

MHRA

2010/006/011/081/017

FSN

Volker AG - Bed

2010/10/27

Southern Care Systems SPECTRA X-Y Link Ceiling Track Hoist Model: HS200XY, H162 & H160 and PARTS Ref: HXYL XY Link

MHRA

2010/003/011/401/011

FSN

Southern Care Systems Ltd.

2010/10/27

Philips Healthcare Philips M1567A & M1568A Single and Dual Disposable Pressure Transducer (DPT) Kits

MHRA

2010/010/022/081/010

FSN

Philips Electronic Hong Kong Ltd

2010/10/27

Maquet Power Cord 3113.3659/ 0223.2824 supplied together with the mobile operating tables of the ALPHACLASSIC, ALPHASTAR, BETASTAR and ALPHAMAXX series

MHRA

2010/009/015/401/003

FSN

Maquet Hong Kong Ltd.

Johnson & Johnson Medical (HK) Ltd.

N.A.

Firm Initiated Field Action

Johnson & Johnson (Hong Kong) Ltd.

2010/10/27

Johnson & Johnson 1 Day Acuvue TruEye Contact Lens

2010/10/28

Trumpf Medical Systems Ltd Trumpf KlinoPORT Ceiling Supply Unit

MHRA

2010/010/022/081/004

FSN

N.A.

2010/10/28

Gambro Lundia AB Gambro Accessory S-660-C

MHRA

2010/010/021/081/026

FSN

Gambro Lundia AB

2010/10/28

Kirton Healthcare Group Ltd Kirton DBO Chair

MHRA

2010/006/018/291/019

FSN

N.A.

2010/10/28

Conmed Pediatric/Neonatal Pre-attached Wire ECG Electrodes (Neotrade, Neotrade II, Softrace Neonatal, Softrace Pediatric And Softrace Limb Band)

MHRA

2010/009/027/081/016

FSN

Conmed Corporation

2010/10/29

Independence Technology iBOT 4000 Mobility System Battery pack. Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s)

FDA

Z-1775-2010

Class II

Johnson & Johnson Medical (HK)

2010/10/29

Toshiba PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems

FDA

Z-1997-2010

Class II

Sanko Medical Systems (HK) LTD

2010/10/29

Linvatec Advantage Turbo 2-Button Shaver. Rx Only

FDA

Z-2026-2010

Class II

N.A.

2010/10/29

International Technidyne 1) GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. 2) GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk.

FDA

Z-2107-2010; Z-2108-2010

Class II

Vastec Medical Ltd.

2010/10/29

AGFA IMPAX CV Results Manager/Results Manager Administration Tool. Model No. L9M2100. Software Versions RM 2.08.12.00.00

FDA

Z-2112-2010

Class II

AGFA Hong Kong Limited

2010/10/29

Spacelabs Healthcare BleaseSirius Anaesthesia System, gas machine

FDA

Z-2113-2010

Class II

N.A.

2010/10/29

Smith & Nephew 1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST, REF 71163006. 2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST, REF 71163008.

FDA

Z-2197-2010 thru Z-2199-2010

Class II

Smith & Nephew LTD

2010/10/29

Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers: PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52.

FDA

Z-2399-2010

Class II

N.A.

2010/10/29

Stryker Sonopet Ultrasonic Surgical System, Model UST-2001

FDA

Z-2640-2010

Class II

Stryker China Ltd