Medical devices, 2012: every recall, from FDA

Medical device recall Colgate Adult Motion Battery Toothbrush Brush battery cap was forcibly blown off at the end of the brush handle. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Colgate Adult Motion Whitening Battery Toothbrush Brush battery cap was forcibly blown off at the end of the brush handle. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist Brush battery cap was forcibly blown off at the end of the brush handle. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Colgate 360 Replaceable Head Battery Powered Toothbrush Soft Brush battery cap was forcibly blown off at the end of the brush handle. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft Brush battery cap was forcibly blown off at the end of the brush handle. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CUSTOM CPB CATHETER KIT-DR During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are… During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named

Medical device recall Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Kansas, Kentucky, Michigan, Mississippi, North Carolina, North Dakota, New Jersey, Ohio, Oklahoma, Tennessee, Texas, Utah and Wisconsin named

Medical device recall Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product… HeartStart MRx Unexpected Pads/Paddles ECG Failure Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kansas, Pennsylvania and Texas named

Medical device recall MULTIGENT Acetaminophen for use with Architect/Aeroset Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereIllinois

Medical device recall PTS Panels Creatinine test strips During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter… Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named

Medical device recall ARCHITECT CA 19-9XR Reagent Kit The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Texas, Virginia and Washington named

Medical device recall NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall NIDEK Medical NUVO LITE Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W Capacitor failure may result in a fire hazard and loss of supplemental oxygen. FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva… FDA Class I, its most serious class Class IFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 27, 2012ClassClass IStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Missouri and Virginia named

Medical device recall PrepStain Syringing Pipettes 240 (Catalog #490517) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall PrepStain Installation Kit (PreCoat) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall Manual Method 1: 480 Test Kit (PreCoat) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall PrepStain GN 480 Disposable Kit The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive,… Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2012

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