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Medical device recalls reported in 2013

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ReportedRecallClassProductFirm
2013-01-16Z-0647-2013Class IIIImmunoradiometric assaySiemens Healthcare Diagnostics
2013-01-16Z-0648-2013Class IIIImmunoradiometric assaySiemens Healthcare Diagnostics
2013-01-16Z-0649-2013Class IISterile Rigid Tip Suction Wand The Suction Wands are indicated for…California Medical Laboratories Inc
2013-01-16Z-0650-2013Class IIRigid Tip Suction Wand Non sterile bulk devicesCalifornia Medical Laboratories Inc
2013-01-16Z-0651-2013Class IIUltrafill DBM labeled in part: TISSUENET Sterilized by T10^6…Surgical Tissue Network, Inc.
2013-01-16Z-0652-2013Class IIUltraFill DBM labeled in part: TISSUENET Sterilized by T10^6…Surgical Tissue Network, Inc.
2013-01-16Z-0653-2013Class IIUltraFill DBM labeled in part: TISSUENET Sterilized by T10^6…Surgical Tissue Network, Inc.
2013-01-16Z-0655-2013Class IIFlowGate Balloon Guide CatheterConcentric Medical Inc
2013-01-16Z-0656-2013Class IIAccolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2Stryker Howmedica Osteonics Corp.
2013-01-16Z-0657-2013Class II(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3)…Stryker Communications, Inc.
2013-01-16Z-0658-2013Class IIAutoPulse Resuscitation System Model 100Zoll Circulation, Inc.
2013-01-16Z-0659-2013Class IIThe TM Ardis Interbody System Inserter Stainless SteelZimmer, Inc.
2013-01-16Z-0660-2013Class IIPT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct…Biomet, Inc.
2013-01-16Z-0661-2013Class IISTERRAD NX CassettesAdvanced Sterilization Products
2013-01-16Z-0662-2013Class IICARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used…Maquet Cardiovascular, LLC
2013-01-16Z-0663-2013Class IIMerit Medical's Custom Procedural Tray or Kits K12T-03162B &ampMerit Medical Systems, Inc.
2013-01-16Z-0664-2013Class IIEmitSiemens Healthcare Diagnostics, Inc.
2013-01-16Z-0665-2013Class IIISiemens EmitSiemens Healthcare Diagnostics, Inc.
2013-01-09Z-0617-2013Class IIIFast-Cath Transseptal Guiding IntroducerSt Jude Medical Inc
2013-01-09Z-0618-2013Class IIMedtronic Intersept Custom Tubing Pack with or without coatingMedtronic Inc. Cardiac Rhythm Disease Management
2013-01-09Z-0619-2013Class IIIAnalyzing system consists of a small and portable analyzer and…HemoCue AB
2013-01-09Z-0620-2013Class IICompanion External BatterySynCardia Systems Inc.
2013-01-09Z-0621-2013Class IFisher & Paykel Healthcare reusable breathing circuitFisher & Paykel Healthcare, Ltd.
2013-01-09Z-0622-2013Class IILiko Standard Slingbar 450Hill-Rom, Inc.
2013-01-09Z-0623-2013Class IISpace Pump Pole Clamps for the Infusomat Space PumpB. Braun Medical, Inc.
2013-01-09Z-0624-2013Class IIPlum A+ Single Channel Infusion PumpsHospira Inc.
2013-01-09Z-0625-2013Class IIPlum A+3 Triple Channel Infusion PumpsHospira Inc.
2013-01-09Z-0626-2013Class IIPlum A+ Hyperbaric Single Channel Infusion PumpsHospira Inc.
2013-01-09Z-0627-2013Class IIMaquet Yuno Extension Table Device Maquet GmbH & CoMaquet Inc.
2013-01-09Z-0628-2013Class IIMedical Surgical BedStryker Medical Division of Stryker Corporation
2013-01-09Z-0629-2013Class IIMedical Surgical BedStryker Medical Division of Stryker Corporation
2013-01-09Z-0630-2013Class IIDPM Central Station Mindray DS USAMindray DS USA, Inc. d.b.a. Mindray North America
2013-01-09Z-0631-2013Class IIAVAIRACooper Vision Caribbean Corp.
2013-01-09Z-0632-2013Class IIABX PENTRA AST CPHoriba Instruments, Inc dba Horiba Medical
2013-01-09Z-0633-2013Class IIPENTRA C200Horiba Instruments, Inc dba Horiba Medical
2013-01-09Z-0634-2013Class IIAbbott m2000sp InstrumentAbbott Molecular
2013-01-02Z-0479-2013Class IIComputed Tomography X-Ray SystemPhilips Medical Systems (Cleveland) Inc
2013-01-02Z-0525-2013Class IPraxair Vantage Grab n GoPraxair Inc.
2013-01-02Z-0594-2013Class IZimmer Spine Ardis InserterZimmer, Inc.
2013-01-02Z-0606-2013Class IGE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece…GE Healthcare, LLC
2013-01-02Z-0608-2013Class IIIQualicheck 1+Radiometer America Inc
2013-01-02Z-0609-2013Class IIDiamigo i-Phone App The Diamigo app was intended for use as an…sanofi-aventis US, Inc.
2013-01-02Z-0610-2013Class IIStryker Howmedica OsteonicsStryker Howmedica Osteonics Corp.
2013-01-02Z-0611-2013Class IIBiosense Webster MobiCath Bi-Directional Guiding SheathGreatbatch Medical
2013-01-02Z-0612-2013Class IIAccess Immunoassay SystemBeckman Coulter Inc.
2013-01-02Z-0613-2013Class IIAccess Immunoassay Systems Total T4 CalibratorsBeckman Coulter Inc.
2013-01-02Z-0614-2013Class IICOBAS AmpliPrep InstrumentRoche Molecular Systems, Inc.
2013-01-02Z-0615-2013Class IIFlowtron Trio DVT PumpArjo, Inc. dba ArjoHuntleigh
2013-01-02Z-0616-2013Class IIBrookstone Heated Body BeanBrookstone Company, Inc.

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