Medical devices, 2013: every recall, from FDA

Medical device recall Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40… Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, New Jersey and New York named

Medical device recall (l) Visum Halogen Surgical Light Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AutoPulse Resuscitation System Complaints associated with an unexpected stop in AutoPulse compressions. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder,… Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall STERRAD NX Cassettes, P/N 10133 Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic… In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportIdahothe one state its words name PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereIdaho

Medical device recall Merit Medical’s Custom Procedural Tray or Kits K12T-03162B &amp Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereMississippi and New Jersey

Medical device recall Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2,… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement Report18 statesnamed in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Washington

Medical device recall Siemens Emit(R) tox(TM) Serum Calibrators Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall Fast-Cath Transseptal Guiding Introducer, 90, 8F St. Class IIIFDA’s classJan 9, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 9, 2013ClassClass IIIStatusTerminatedWhereFlorida, Kentucky and Oklahoma

Medical device recall Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive… Medtronic is initiating an Urgent Medical Device Customer Notification. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Massachusetts, Maryland, Michigan, Mississippi, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Wisconsin named

Medical device recall Analyzing system consists of a small and portable analyzer and plastic microcuvettes Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. Class IIIFDA’s classJan 9, 2013in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 9, 2013ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Texas and Utah

Medical device recall Companion External Battery Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Fisher & Paykel Healthcare reusable breathing circuit FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. FDA Class I, its most serious class Class IFDA’s classJan 9, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 9, 2013ClassClass IStatusTerminatedWhereArkansas, Georgia, Illinois and Indiana

Medical device recall Liko Standard Slingbar 450 Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, West Virginia and Wyoming named

Medical device recall Space Pump Pole Clamps for the Infusomat Space Pump Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, North Carolina and Tennessee named

Medical device recall Plum A+ Single Channel Infusion Pumps The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 9, 2013ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall Plum A+3 Triple Channel Infusion Pumps The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 9, 2013ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall Plum A+ Hyperbaric Single Channel Infusion Pumps The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 9, 2013ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall Maquet Yuno Extension Table Device Maquet GmbH & Co There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereArkansas, Georgia, South Carolina, Tennessee and Texas

Medical device recall Medical Surgical Bed Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring… There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Ohio named

Medical device recall AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses The lenses exceeded the acceptance limit for silicone oil residual. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall ABX PENTRA AST CP Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New York, Oklahoma, Texas and Virginia named

Medical device recall PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using… Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New York, Oklahoma, Texas and Virginia named

Medical device recall Abbott m2000sp Instrument An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator… Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW) Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named

Medical device recall Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Isolated incidents of ignition inside Grab n’ Go cylinders that had been knocked over or otherwise subject to significant physical impact. FDA Class I, its most serious class Class IFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2013ClassClass IStatusTerminatedWhereNationwide

Medical device recall Zimmer Spine Ardis Inserter, Rx, non-sterile Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. FDA Class I, its most serious class Class IFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJan 2, 2013ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Wisconsin and West Virginia named

Medical device recall GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable… Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out… FDA Class I, its most serious class Class IFDA’s classJan 2, 2013in FDA’s Enforcement Report47 statesnamed in where it went PublishedJan 2, 2013ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall Qualicheck 1+, Aqueous Quality Control, Level 2, S7140 The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. Class IIIFDA’s classJan 2, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 2, 2013ClassClass IIIStatusTerminatedWhereKentucky, North Carolina and New York

Medical device recall Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the… Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Stryker Howmedica Osteonics During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, Illinois, Indiana, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon and Texas named

Medical device recall Biosense Webster MobiCath Bi-Directional Guiding Sheath Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection… Class IIFDA’s classJan 2, 2013in FDA’s Enforcement Report40 statesnamed in where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin

Medical device recall Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i… It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive… Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Access Immunoassay Systems Total T4 Calibrators A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month… Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument… Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release… Class IIFDA’s classJan 2, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Minnesota and North Carolina

Medical device recall Flowtron Trio DVT Pump The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall Brookstone Heated Body Bean, electrically heated Additional Warning Statement to prevent burns to the skin Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2013

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