The following document is a summary of some medical device safety information related to potentially hazardous cases. It only serves as a quick reference and in no way should be considered as exhaustive and up-to-date. Please refer to the source of information and contact manufacturer or local supplier for details. (Updated on 2 February 2012).
| Summary for the Current Year |
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| Summary for Previous Years |
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[1 February 2012] Field Safety Notice: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System |
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[1 February 2012] Field Safety Notice: Abbott Molecular Bar Code Scanner User's Guide |
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[1 February 2012] Field Safety Notice: TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore |
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[31 January 2012] Statement on Metal-on-Metal Hip Replacement Implants issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), UK |
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[26 January 2012] Field Safety Notice: Biomet Microfixation Sternalock Blu Implant Tray |
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[26 January 2012] Field Safety Notice: Terumo CDI™ Blood Parameter Monitoring System 500 |
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[16 January 2012] Field Safety Notice: Recall of Covidien Duet TRS™ Universal Straight and Articulating Single Use Loading Units |
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[13 January 2012] FDA Class I Recall: Respironics Trilogy 100 Ventilators |
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[13 January 2012] Field Safety Notice: Terumo® Advanced Perfusion System 1 |
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[12 January 2012] Field Safety Notice: Given Imaging Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles) |
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[10 January 2012] MHRA Field Safety Notice: SynCardia Companion 2 Driver System |
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[4 January 2012] Field Safety Notice: HeartWare® Ventricular Assist System |
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[4 January 2012] Field Safety Notice: SynCardia Freedom Driver System |
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[28 December 2011] Field Safety Notice: Sierra Scientific Instruments ManoShield™ AR |
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[23 December 2011] Field Safety Notice: Smiths Medical Voluntary Recall for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets |
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[23 December 2011] Field Safety Notice: Johnson & Johnson Vision Care 1 Day Acuvue® TruEye™ (Narafilcon B) Contact Lenses |
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[20 December 2011] Field Safety Notice: Update of the Instructions for Use of DLPR Single Stage Venous Cannulae |
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[14 December 2011] Field Safety Notice: Elekta Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.) |
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[13 December 2011] Field Safety Notice: Amendments to instructions for use of CERAGEM-E Massage Bed |
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[13 December 2011] Field Safety Notice: Smiths Medical Graseby MR10 Neonatal Respiration Monitor |
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[8 December 2011] Field Safety Notice: Bausch & Lomb Crystalens® Accommodating Posterior Chamber Intraocular |
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[6 December 2011] Field Safety Notice: 4Care AG's SH-System Monatslinsen contact lenses |
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[6 December 2011] Field Safety Notice: Metrex Research Pinnacle Syringe Sleeves |
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[5 December 2011] Field Safety Notice: CLR Medicals International Inc., Visco Supreme |
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[2 December 2011] Field Safety Notice: Beavers Dental FG 1/2 Burs |
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[2 December 2011] Field Safety Notice: Pentron Clinical Correct Plus Berry Putty Auto Mix |
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[2 December 2011] Field Safety Notice: Pentron Clinical Artiste Nano-Hybrid Flowable Composite |
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[2 December 2011] Field Safety Notice: Beavers Dental LA 5 Burs |
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[29 November 2011] Field Safety Notice: Abbott Vascular RX Accunet Embolic Protection System |
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[29 November 2011] Field Safety Notice: Sybron Dental Specialties Freedom Cordless LED Headlight |
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[29 November 2011] Field Safety Notice: Cordis SUPER TORQUER MB Angiographic Catheter |
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[28 November 2011] Field Safety Notice: Medtronic Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006) |
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[25 November 2011] Field Safety Notice: Varian C-Series Clinac or Trilogy, versions 7.x and 8.x |
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[25 November 2011] Field Safety Notice: Impulse Dynamics OPTIMIZERR III Implantable Pulse Generator |
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[23 November 2011] Field Safety Notice: Terumo CVS Sarns™ Sternal Saw I System |
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[23 November 2011] MHRA Field Safety Notice: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads |
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[22 November 2011] MHRA Field Safety Notice: Mindray V series patient monitor |
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[17 November 2011] Medical Device Recall : Coloplast Catheter Valve |
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[17 November 2011] Field Safety Notice: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0 |
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[17 November 2011] Field Safety Notice: Varian Eclipse Release 10 with ARIAT Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34) |
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[15 November 2011] Field Safety Notice: Brainlab BrainSCAN version 5.31 and 5.32 |
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[15 November 2011] Health Canada Type II Recall: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347) |
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[15 November 2011] MHRA Field Safety Notice: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs |
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[15 November 2011] Health Canada Type I Recall: Zevex Ambulatory Infusion Pumps Painsmart IOD, 6000 CMS, and 4000 CMS |
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[15 November 2011] MHRA FSN Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A |
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[14 November 2011] Medical Device Recall: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths |
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[8 November 2011] Field Safety Notice: Varian TrueBeam and TrueBeam STx |
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[1 November 2011] Product Recall: Synthes A2FN Reamer |
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[31 October 2011] Field Safety Notice: Boston Scientific SCS Remote Control (RC), Charger, External Trial Stimulator, Trial Patient Belt & Charger Belt |
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[28 October 2011] Field Safety Notice: Boston Scientific COGNISR, TELIGENR, INCEPTATM, PUNCTUATM, and ENERGENTM CRT-Ds and ICDs, and LATITUDER remote patient monitoring system |
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[24 October 2011] Field Safety Notice: Drager Delta, Delta XL, Vista XL, Gamma XXL and Kappa |
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[24 October 2011] Field Safety Notice: Immucor Gamma Complement Control Cells, lot 34161 |
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[21 October 2011] FDA Field Safety Notice: Cardiac Science Corporation Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440 |
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[21 October 2011] TGA Class II Recall: Oto-Ease ear lubricant |
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[21 October 2011] FDA Class I Recall: CareFusion EnVe Ventilators |
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[19 October 2011] Field Safety Notice: Elekta XVI 4.5 and 4.6 |
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[18 October 2011] Urgent Field Safety Notice: "Choice for Health" Various Bandages |
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[18 October 2011] Field Safety Notice: Boston Scientific TWISTERTM Rotatable Polyp Retrieval Device |
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[17 October 2011] Urgent Field Safety Notice: Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28) |
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[14 October 2011] FDA Educational Materials: Decorative Contact Lenses
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[13 October 2011] Urgent Product Recall: BD Oral Syringe with Syringe Tip Caps
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[13 October 2011] Urgent Field Safety Notice: Abbott m2000sp Instrument
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[13 October 2011] Field Safety Notice: InfinityR Acute Care System (IACS) Monitoring Solution
with software versions VG1, VG1.2 and VG1.3
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[11 October 2011] MHRA Field Safety Notice: Breathing System Components |
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[11 October 2011] MHRA Field Safety Notice: Octopus-3 x Anti-reflux Valves + Clamps |
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[7 October 2011] Urgent Field Safety Notice: Varian FrameArray Module HZ7 and Floorstand HZ5 |
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[6 October 2011] Health Canada Type II Recall: Warmair Model 134 |
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[4 October 2011] Field Safety Notice: Hospira All Plum A+ family of Infusers |
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[4 October 2011] Field Safety Notice: Synthes Anspach Single-use Cutting Burs and Irrigation Clips |
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[30 September 2011] Field Safety Notice: Terumo CVS CDI Blood Parameter Monitoring System 500 |
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[30 September 2011] MHRA Medical Device Alert: Reusable laryngoscope handles |
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[28 Sept 2011] Voluntary Product Recall: Bausch & Lomb Soflens 59, lot W12010319 |
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[23 Sept 2011] Urgent Field Safety Notice: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4) |
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[22 Sept 2011] Field Safety Alert: Gemstar docking station (model number:13075) |
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[20 Sept 2011] FDA Class I Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits |
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[15 Sept 2011] Urgent Field Safety Notice: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators |
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[14 Sept 2011] Voluntary Recall Notification: Cochlear Nucleus CI500 cochlear implant range |
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[8 September 2011] Urgent Field Safety Notice: RT Chart function of ARIA™ |
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[7 September 2011] Field Safety Notice: Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor |
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[2 September 2011] FDA Class I Recall: Boston Scientific Innova™ Self-Expanding Stent System |
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[31 August 2011] Robinson Healthcare Cotton Gauze Tissue BP 45x90cm |
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[30 August 2011] Abbott Diagnostic Clinical Chemistry Alkaline Phosphatase Reagent |
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[29 August 2011] Urgent Field Safety Notice: Eclipse 10 (Client builds
10.0.28 and 10.0.34) |
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[18 August 2011] 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1 |
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[18 August 2011] Medical Device Removal: Terumo Level Sensor II Pads |
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[15 August 2011] Boston Scientific Expect™ Endoscopic Ultrasound Aspiration Needle |
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[9 August 2011] Boston Scientific Katzen™ Infusion Wire |
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[5 August 2011] Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between April 14, 2011 and May 9, 2011 |
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[4 August 2011] Use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws |
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[4 August 2011] Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20 |
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[4 August 2011] GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits |
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[3 Aug 2011] FDA Class I Recall: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System |
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[27 July 2011] Coseal Surgical Sealant |
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[26 July 2011] 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3 |
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[20 July 2011] Field Safety Notice: Boston Scientific Resolution® II Clip |
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[20 July 2011] TomoTherapy Treatment Systems HiĦEArt versions 4.0.x, and HD versions 1.0.x |
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[20 July 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30 |
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[17 July 2011] Thermo Fisher Scientific, Thermo Scientific Microm HM355S |
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[17 July 2011] Boston Scientific PROMUS ElementTM Everolimus-Eluting Coronary Stent System |
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[14 July 2011] FDA Updates on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse |
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[14 July 2011] Alert on product recall : Banitore Basic Dressing Pack |
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[11 July 2011] Smith & Nephew, Tendon Stripper, slotted, 5.0 mm I.D. x 12Ħ¨ working length. |
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[8 July 2011] Varian Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model: H48 |
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[7 June 2011] GE Healthcare Power supply for TruSat Pulse Oximeter |
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[24 May 2011] Beckman Coulter Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell (Model affected: LX20 - 466200, LX20 PRO - 476100, LXi 725 - 476501) |
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[13 May 2011] Nova StatStrip Glucose Hospital Monitoring System |
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[13 May 2011] Siemens LANTIS Commander, LANTIS
Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential |
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[3 May 2011] Roche Diagnostics Ltd. Process System Manager (PSM) Software |
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[26 April 2011] EclipseTM Treatment Planning System |
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[21 April 2011] Sunrise Medical Quickie Neon Swing-Away manual wheelchairs |
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[14 April 2011] Penumbra Coil 400 |
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[14 April 2011] iCAD AxxentR FlexiShield Mini, Model F5300 |
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[13 April 2011] Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD |
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[30 March 2011] Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75 and DI150 |
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[23 March 2011] Kerr Corporation OptiBond FL Adhesive Refill (Model no. 25882) |
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[23 March 2011] BioLytical Laboratories INSTI 24 Test Kit without Support Materials (Model no. 62013) |
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[23 March 2011] Fresenius Medical Care Optiflux F250NRe Dialyzers |
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[18 March 2011] Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M. tuberculosis Complex, ACCUPROBE M. avium Complex |
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[15 March 2011] Unomedical (a ConvaTec company) Endotracheal (ET) tubes, adult and paediatric sizes |
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[15 February 2011] Invitrogen HLA (human leukocyte antigen) tissue typing kits |
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[10 February 2011] Philips HeartStart MRx (M3535A/M3536A) with software versions F.01.00 or F.01.01 |
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[7 February 2011] Maquet Cardiovascular, LLC Heartstring II Proximal Seal System |
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[7 February 2011] Arstasis Inc One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010 |
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[27 January 2011] FDA review indicates possible association between breast implants and a rare cancer |
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[20 January 2011] B Braun Outlook 400ES Safety Infusion System |
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[20 January 2011] Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 and 03-2795-7 |
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[7 January 2011] Unomedical Nasogastric feeding tube |
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[7 January 2011] Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks |
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[23 December 2010] Abbott Glucose Test Strips Precision Xceed Pro; Precision Xtra;
Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima |
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[23 December 2010] SCC Soft Computer SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16 |
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[23 December 2010] BioMerieux Inc VITEK 2 Gram Negative Susceptibility Card |
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[22 December 2010] Varian Medical Clinac Linear Accelerator, Trilogy Radiotherapy Delivery System, Clinac IX Radiotherapy Delivery System, Novalis TX Linear Accelerator and Acuity Radiation Therapy Stimulator |
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[22 December 2010] Fresenius Medical Care Combiset Blood Volume Monitor Bloodline |
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[22 December 2010] Fresenius Red Blood Cell (RBC) Set (catalog number 9007601) |
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[15 December 2010] All makes Umbilical cord clamps |
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[10 December 2010] Tyco Healthcare Puritan Bennett 840 ventilator |
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[10 December 2010] Hospira Symbiq One-Channel Infuser LIST No. 16026; Symbiq Two-Channel Infuser, List No. 16027 |
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[30 November 2010] Varian C-Series Clinacs (Models H14, H18, H29) |
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[24 November 2010] Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons; Otological Ventilation Tubes |
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[20 November 2010] Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II (Prothrombin), C) MagNA Pure LC 2.0 Instrument |
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[6 November 2010] Confluent Surgical Pleuraseal Lung Sealant System |
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[14 October 2010] Multi-Med Huber needles |
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[13 October 2010] CareFusion Alaris PC Unit Model 8000 |
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[13 October 2010] CareFusion Alaris PC Unit Model 8015 |
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[29 September 2010] Lifescan A) OneTouch DataLink Data Management System,
B) OneTouch DataLink Management System |
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[29 September 2010] Beckman Coulter Clinical Chemistry Analyzer A) AU5400, B) AU2700, C) AU400, AU400E, D) AU600, AU640, AU640E, E) AU680, F) AU480 |
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[29 September 2010] James Spencer All Ventnor mobile shower chairs |
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[21 September 2010] All brands Intravenous (IV) extension sets with multiple ports |
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[17 September 2010] Kimal K-Flow Access Catheters; Kimal High Flow (HF) Haemodialysis Catheters; Kimal Right Atrial (KRA) Catheters |
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[16 September 2010] Symbiq One- and Two- Channel Infuser. List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54 |
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[15 September 2010] Sequal Eclipse Oxygen System. (Lot: 073002972, 063005184, 073006282, 073000585, 073007840, 073006062, 073002301, 073004651,073003155,073004456) |
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[10 September 2010] Roche Diagnostics A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas C-System B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers |
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[9 September 2010] AngioScore AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system |
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[8 September 2010] DePuy ASR Hip Replacement Implants (Updated) |
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[7 September 2010] Various Manufacturer - IV Extension sets with multiple ports and vented caps |
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[21 August 2010] Immuncor Panoscreen I, II & III |
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[20 August 2010] St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838, 3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3110892, 3118797, 3107789, 3107790) |
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[14 August 2010] St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838, 3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3107789, 3107790) |
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[11 August 2010] Ikaria INOMAX DS drug-delivery systems |
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[31 Jul 2010] Rehabilitation Centre for Children Tilt Standing Frame |
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[31 July 2010] B. Braun AddEase Binary Connector |
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[30 July 2010] Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System. Medical device (Product codes: GXMRSA/SA-BC-10, Lot 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302; Product code: GXMRSA/SA-BC-CE-10, Lot 01001, 01101, 01301) |
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[30 July 2010] Multi-Med 22ga x 1" Straight Huber Needle (Model number 10600218, Lot 9B020M), 22ga x 1" Right Angle Huber Needle (Model number 10600219, Lot 9B017M). |
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[3 July 2010] Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot Numbers: 00401, 00502, 00701, 00702, 00501) |
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[19 June 2010] Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505-2001) and Calcium Sulfate Hemihydrate Kit, 0.5g (Model or Catalog#505-2002) |
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[19 June 2010] Remington Disposable Surgical Extension Cable (Model or Catalog#
FL-601-97, Lot or Serial# 100701) |
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[19 June 2010] Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440116, 71440118) |
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[10 June 2010] Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770) |
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[9 June 2010] C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are not Bard-manufactured products |
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[1 June 2010] Philips HeartStart FR2+ Automated External Defibrillator |
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[31 May 2010] Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors |
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[28 May 2010] Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product Ref: from 48389407 to 48389418) |
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[20 May 2010] Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X) and Cardiovascular Procedure Kits containing pumps from affected lots |
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[18 May 2010] Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold under the brand names Lifeline AED and ReviveR AED (serial no.: between 202001005 and 202005916, or between 206001001 and 206009871) |
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[13 May 2010] Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED (Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model M5067A), HeartStart HS1 Defibrillator (Model M5068A) |
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[12 May 2010] Heartware Ventricular Assist System Controller |
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[11 May 2010] GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1 |
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[7 May 2010] Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) |
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[7 May 2010] Varian Varisource iX Console |
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| Important notices
