Medical devices, 2013: every recall, from FDA

Medical device recall Clinical Chemistry Phenobarbital, list number 1E08 Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur Vitamin D Assay Negative bias in patient samples for Vitamin D Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur Vitamin D Calibrator 2-pack Negative bias in patient samples for Vitamin D Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur Vitamin D Calibrator 6-pack Negative bias in patient samples for Vitamin D Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level… Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report44 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation… A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Oxford Partial Knee Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Indiana named

Medical device recall SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters SR Instruments Inc. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named

Medical device recall LifeScan brand OneTouch¿ Ultra Control Solution When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall LifeScan brand OneTouch¿ Select Control Solution When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which… The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New York, Oklahoma and Virginia named

Medical device recall TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Michigan, Missouri, North Carolina, Ohio and South Carolina named

Medical device recall GE Healthcare Muse v7 cardiology information system GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportUS Virgin Islandsthe one state its words name PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereUS Virgin Islands

Medical device recall Edwards Lifesciences Crimpers Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, North Carolina, Nevada, Oregon, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall GE Healthcare, AW Server GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall OsteoSelect DBM Putty Product Usage: Orthopedic bone filler The firm’s retesting procedure was not validated. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Alere Cholestech LDX ALT AST Test Cassette The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Duane Reade TRUEtrack monitor kit Meter kit outer boxes containing 10 ct. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and New York named

Medical device recall HORIBA ABX PENTRA 400 I.S.E HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Indiana, Louisiana, Michigan, Minnesota, New Jersey, New Mexico, New York, Ohio, Puerto Rico, South Carolina, Texas and Virginia named

Medical device recall Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass… Distribution of an unapproved device into interstate commerce. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNew York, Pennsylvania and Texas

Medical device recall Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise… Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Iowa, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas and Utah

Medical device recall ACIST Medical Systems Inc ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named

Medical device recall Pressure Monitoring sets with VAMP Plus closed blood sampling system The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Hawaii, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic… Transonic Systems Inc. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, New Mexico, New York, Texas, Virginia and Washington named

Medical device recall IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma) Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. Class IIIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 24, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Georgia, Kansas, Kentucky, Massachusetts, Minnesota, New York, Pennsylvania, Tennessee, Utah, Vermont and Washington named

Medical device recall MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp… It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004 Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens Dimension Vista(R) System Vista Drug 4 Calibrator Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement Report46 statesnamed in where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880… Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a… FDA Class I, its most serious class Class IFDA’s classApr 17, 2013in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 17, 2013ClassClass IStatusTerminatedWhereArkansas, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia

Medical device recall Respironics SealFlex Single Port Ribbed Mask (Infant) The mask inside the package has been identified as “Neonatal” in size and not “Infant” as the labeling indicates. FDA Class I, its most serious class Class IFDA’s classApr 17, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 17, 2013ClassClass IStatusTerminatedWhereCalifornia, Colorado, Indiana, New York and Pennsylvania

Medical device recall Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Flexible Grip which is part of the Synthes Universal Nail System Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Stelkast Cross-over Acetabular Shell and Liner Hip System Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Nevada, Oklahoma and Pennsylvania named

Medical device recall TSX-IOI: AQUILION 32/64 The firm initiated this recall due to a potential software issue. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Hawaii, Illinois, Maine, Montana, North Carolina, Ohio, Texas, Washington, Wisconsin and West Virginia named

Medical device recall Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportMarylandthe one state its words name PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereMaryland

Medical device recall IMPAX CV 7.8 SU3 - OCR Service Software design error in IMPAX CV 7.8 SU3 Class IIFDA’s classApr 17, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereFlorida and Kentucky

Medical device recall IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the… Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Georgia, Illinois, Kentucky, Massachusetts, North Carolina, New York, Rhode Island, South Carolina, Texas and Virginia named

Medical device recall Posey Biothane Restraint Cuffs The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Precise Treatment Table The Column rotation can accidentally be moved to a different position which in the locked position. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical devices, 2013

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