Medical devices, 2012: every recall, from FDA

Medical device recall Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Pennsylvania, South Carolina, Texas and Utah named

Medical device recall System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the… Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Michigan, Missouri, Ohio and South Carolina

Medical device recall Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is… Please be aware that this is not a new recall. FDA Class I, its most serious class Class IFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative… software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and… software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and… software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective… When users selected “Left stenosis” in the “Graft Duplex Conclusion” section in IMPAX CV Reporting Non-Invasive(NIV) module, “Right stenosis” appeared in the… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Ohio, South Carolina and Texas named

Medical device recall Product is labeled in part: “***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T,… Exactech, Inc. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Ohio and Oklahoma

Medical device recall Product is labeled in part: “***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF… Exactech, Inc. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts, Ohio and Oklahoma

Medical device recall ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and… Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X)… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereFlorida

Medical device recall BridgePoint Medical, Stingray Catheter BridgePoint Medical Inc. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, North Carolina, New York, Oregon, Pennsylvania, Washington and Wisconsin named

Medical device recall Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites… The float valve in the burette sticks to the burette wall and does not open or close properly. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming named

Medical device recall Alaris PC unit The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630)… FDA Class I, its most serious class Class IFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall .***ANSPACH***Sterile Anspach Effort, Inc. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona and California named

Medical device recall Siemens syngo.plaza Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Washington and Wisconsin named

Medical device recall Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate… Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereIndiana, Kansas, Maryland, New Mexico and Texas

Medical device recall Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm Imaging artifact can occur on mammogram result Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with… A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as… During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of… Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Ohio and Texas named

Medical device recall Tibial Punch Tower Assembly Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall PrepStain Kit: 1.2 DiTi Cone Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall PrepStain Slide Processor Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall PrepStain PM Kit, T-AG (Catalog 490588) Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusOngoingWhereNationwide

Medical device recall Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland… Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusOngoingWhereNationwide

Medical device recall Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed ‘G03’), 686E030003,… Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip… FDA Class I, its most serious class Class IFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJul 25, 2012ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall GE Healthcare Optima Mobile X-ray System GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical… CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it… FDA Class I, its most serious class Class IFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJul 25, 2012ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Kentucky, Maine, Michigan, Minnesota, Missouri, Montana, North Dakota, New Jersey, New Mexico, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Wisconsin and West Virginia named

Medical device recall Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient’s fluids… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Nebraska and South Dakota named

Medical device recall Terumo Advanced Perfusion System 1 System 1 Base, 100/120V Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Terumo Advanced Perfusion System 1 System 1 Base, 220/240V Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Bipolar Forceps On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to “Instructions For Use” of Bipolar Forceps not being cleared… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Presage ST2 Assay The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage… Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereCalifornia

Medical device recall Abbott Molecular Bar Code Scanner User’s Guide In the Abbott Molecular Bar Code Scanner User’s Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Oregon and Virginia

Medical device recall Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare, Invasive Blood Pressure Care Cables GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Illinois, Mississippi, New Jersey, Puerto Rico, South Dakota, Tennessee, Texas and Virginia named

Medical device recall Stryker T2 Arthrodesis Nailing System Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Ohio, South Carolina, Tennessee and Virginia named

Medical device recall MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large) Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Ohio, South Carolina, Tennessee and Virginia named

Medical device recall Spacelabs Medical Xprezzon Bedside Monitor There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereFlorida, Iowa and Oklahoma

Medical device recall System 1 Base, 100/120V Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical devices, 2012

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