ev3 NanoCross .014" OTW PTA Dilatation Catheter
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12/28/10
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Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices
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12/21/10
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Penumbra System Reperfusion Catheter 032
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12/08/10
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Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replacement
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11/30/10
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B. Braun addEASE Binary Connector
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11/30/10
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WalkMed, Inc. Triton Pole Mount Infusion Pump
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11/24/10
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Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches
|
11/23/10
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SIGMA Spectrum Infusion Pump Model 35700
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11/12/10
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bioMérieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
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11/10/10
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Hospira Symbiq One and Two Channel Infuser
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11/04/10
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Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1
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11/02/10
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Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)
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10/26/10
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Westmed Inc., BagEasy Manual Resuscitation Devices
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10/13/10
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Avandia (rosiglitazone) AC Memo - 8/23/2010 (PDF - 100KB)
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Symbiq One and Two-Channel Infusers
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09/21/10
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AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter
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09/08/10
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Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
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08/26/10
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Ikaria Holdings, INOMAX DS Drug Delivery System
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08/23/10
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St. Jude Medical 6 French Engage™ Introducer Devices
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08/13/10
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Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
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08/04/10
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Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
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07/20/10
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Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
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07/15/10
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Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
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07/02/10
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CareFusion Corporation, Alaris PC Units (Model 8015)
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10/15/10
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Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
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07/02/10
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Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators
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06/14/10
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Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
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06/10/10
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GE Healthcare Aisys and Avance Anesthesia Systems
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05/17/10
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Certain Cuffed Shiley Tracheostomy Tubes
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05/17/10
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Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
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04/30/10
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Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
|
04/22/10
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Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters
|
04/08/10
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Four Class I Recalls: Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
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03/30/10
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Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm
|
03/17/10
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Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
|
03/11/10
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Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell
|
03/10/10
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Abiomed, Inc., AB5000 Circulatory Support System
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03/10/10
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Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)
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03/08/10
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Thomas Medical Products Inc., Transseptal Sheath Introducer Kits
|
03/08/10
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Baxter HomeChoice and HomeChoice PRO
|
03/03/10
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Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets
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02/26/10
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StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510
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02/26/10
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Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport
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02/04/10
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Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors
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01/28/10
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Edwards Lifesciences Inc., Aquarius Hemodialysis System
|
01/28/10
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ev3 Endovascular, Inc., Trailblazer Support Catheter
|
01/05/10
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