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
