Medical device recalls reported in 2012

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Reported	Recall	Class	Product	Firm
2012-07-04	Z-1870-2012	Class II	Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist	Colgate Palmolive Company
2012-07-04	Z-1871-2012	Class II	Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507…	Colgate Palmolive Company
2012-07-04	Z-1872-2012	Class II	Colgate 360 Replaceable Head Battery Powered Toothbrush Medium…	Colgate Palmolive Company
2012-07-04	Z-1873-2012	Class II	Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC…	Colgate Palmolive Company
2012-07-04	Z-1874-2012	Class II	Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack…	Colgate Palmolive Company
2012-07-04	Z-1875-2012	Class II	Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1876-2012	Class II	SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1877-2012	Class II	SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1878-2012	Class II	SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1879-2012	Class II	FX PACK Product Usage: The Sarns Cardioplegia Cannula and…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1880-2012	Class II	INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1881-2012	Class II	XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1882-2012	Class II	X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1883-2012	Class II	X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1884-2012	Class II	X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1885-2012	Class II	MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1886-2012	Class II	X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1887-2012	Class II	X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1888-2012	Class II	CUSTOM CPB CATHETER KIT-DR	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1889-2012	Class II	CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1890-2012	Class II	CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1891-2012	Class II	CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1892-2012	Class II	CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1893-2012	Class II	CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1894-2012	Class II	CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia…	Terumo Cardiovascular Systems Corporation
2012-07-04	Z-1895-2012	Class II	Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal…	Zimmer, Inc.
2012-07-04	Z-1896-2012	Class II	Philips HeartStart MRx monitor/defibrillators Models: M3535A	Philips Healthcare Inc.
2012-07-04	Z-1897-2012	Class II	Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip…	Ethicon, Inc.
2012-07-04	Z-1898-2012	Class II	Adult Divided Cannula end tidal C)2 sampling w/male luer-lock…	SALTER LABS
2012-07-04	Z-1902-2012	Class II	MULTIGENT Acetaminophen for use with Architect/Aeroset Cat	Sekisui Diagnostics Llc
2012-07-04	Z-1903-2012	Class II	PTS Panels Creatinine test strips	Polymer Technology Systems, Inc.
2012-07-04	Z-1904-2012	Class II	ARCHITECT CA 19-9XR Reagent Kit	Abbott Laboratories
2012-06-27	Z-1774-2012	Class I	NIDEK Medical M5C5/ MARK5 NUVO/STD	Nidek Medical Products Inc
2012-06-27	Z-1775-2012	Class I	NIDEK Medical M5C5/ MARK5 NUVO/OCSI	Nidek Medical Products Inc
2012-06-27	Z-1776-2012	Class I	NIDEK Medical MARK5 NUVO 8 STD	Nidek Medical Products Inc
2012-06-27	Z-1777-2012	Class I	NIDEK Medical MARK5 NUVO 8 /OCSI	Nidek Medical Products Inc
2012-06-27	Z-1778-2012	Class I	NIDEK Medical NUVO LITE MODEL 525 OCSI	Nidek Medical Products Inc
2012-06-27	Z-1779-2012	Class I	NIDEK Medical NUVO LITE MODEL 520 STD	Nidek Medical Products Inc
2012-06-27	Z-1780-2012	Class I	NIDEK Medical NUVO LITE MODEL 925 OCSI	Nidek Medical Products Inc
2012-06-27	Z-1781-2012	Class I	NIDEK Medical NUVO LITE MODEL 925 OCSI	Nidek Medical Products Inc
2012-06-27	Z-1782-2012	Class I	NIDEK Medical MARK5 NUVO / M5C5	Nidek Medical Products Inc
2012-06-27	Z-1787-2012	Class I	GE Healthcare	GE Healthcare, LLC
2012-06-27	Z-1811-2012	Class III	PrepStain Syringing Pipettes 240	Tripath Imaging, Inc.
2012-06-27	Z-1812-2012	Class III	PrepStain GYN 480 Disposable Test Kit with PreCoat Slides	Tripath Imaging, Inc.
2012-06-27	Z-1813-2012	Class III	PrepStain Installation Kit	Tripath Imaging, Inc.
2012-06-27	Z-1814-2012	Class III	Manual Method 1: 480 Test Kit	Tripath Imaging, Inc.
2012-06-27	Z-1815-2012	Class III	PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a…	Tripath Imaging, Inc.
2012-06-27	Z-1816-2012	Class II	Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica…	Stryker Howmedica Osteonics Corp.
2012-06-27	Z-1817-2012	Class II	TX1 Tissue Removal System Console	American Optisurgical Inc
2012-06-27	Z-1818-2012	Class II	Philips Digital Diagnost Software	Philips Healthcare Inc.
2012-06-27	Z-1819-2012	Class II	US-001 Rev A brochure is a two sided tri-fold printed marketing…	Non-Invasive Monitoring Systems, Inc.
2012-06-27	Z-1820-2012	Class II	USA-002 Rev A brochure is a two sided tri-fold printed marketing…	Non-Invasive Monitoring Systems, Inc.
2012-06-27	Z-1821-2012	Class II	Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system	Philips Healthcare Inc.
2012-06-27	Z-1822-2012	Class II	Peak SE Primer Kits	Ultradent Products, Inc.
2012-06-27	Z-1823-2012	Class II	Arrow International	Arrow International Inc
2012-06-27	Z-1824-2012	Class II	HEPARIN LOCK FLUSH SOLUTION	App Pharmaceuticals Llc
2012-06-27	Z-1825-2012	Class II	HEPARIN LOCK FLUSH SOLUTION	App Pharmaceuticals Llc
2012-06-27	Z-1828-2012	Class II	Implant	Biomet 3i, LLC
2012-06-27	Z-1829-2012	Class II	Philips Multi Diagnost Eleva II with swivel cable Product Codes	Philips Healthcare Inc.
2012-06-27	Z-1831-2012	Class II	The product is Pathfinder SL	Spacelabs Healthcare, Llc
2012-06-27	Z-1832-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1833-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1834-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1835-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 6	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1836-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 7	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1837-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 8	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1838-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 8	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1839-2012	Class II	24FR FLEX ART CANN NON STERILE	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1840-2012	Class II	SPECIALTYCARE	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1841-2012	Class II	CUSTOM CPB CATHETER KIT-DR	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1842-2012	Class II	CPB CATHETER KIT- DR	Terumo Cardiovascular Systems Corporation
2012-06-27	Z-1843-2012	Class II	Olympic Cool-Cap System is intended to provide treatment for neonatal…	Natus Medical Incorporated
2012-06-27	Z-1844-2012	Class II	Covidien ROTICULATOR 55-3	Covidien LP
2012-06-27	Z-1845-2012	Class II	Covidien ROTICULATOR 55-4	Covidien LP
2012-06-27	Z-1846-2012	Class II	Covidien ROTICULATOR 30-3	Covidien LP
2012-06-27	Z-1847-2012	Class II	Covidien ROTICULATOR 30-4	Covidien LP
2012-06-27	Z-1848-2012	Class II	Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The…	Covidien LP
2012-06-27	Z-1849-2012	Class II	Medtronic 0-arm Imaging System with Software Version 3	Medtronic Navigation, Inc.
2012-06-27	Z-1850-2012	Class II	Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer…	Boston Scientific Corporation
2012-06-27	Z-1851-2012	Class II	Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer…	Boston Scientific Corporation
2012-06-27	Z-1852-2012	Class II	Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer…	Boston Scientific Corporation
2012-06-27	Z-1853-2012	Class II	VerifyNow P2Y12 Assay	Accumetrics Inc
2012-06-27	Z-1854-2012	Class II	VerifyNow System	Accumetrics Inc
2012-06-27	Z-1855-2012	Class II	seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02…	Genzyme Corporation
2012-06-27	Z-1856-2012	Class II	seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01…	Genzyme Corporation
2012-06-20	Z-1490-2012	Class I	Sigma Spectrum VOLUMETRIC INFUSION PUMP	Baxter Healthcare Corporation
2012-06-20	Z-1538-2012	Class II	Philips Healthcare Practix Convenio Mobile X-ray system Worldwide…	Philips Healthcare Inc.
2012-06-20	Z-1788-2012	Class II	GE Healthcare Revolution XR/d	General Electric Med Systems LLC
2012-06-20	Z-1789-2012	Class II	GE Healthcare Definium 8000 Digital Radiographic Systems : GE…	General Electric Med Systems LLC
2012-06-20	Z-1790-2012	Class II	GE Proteus XR/a Radiographic System	General Electric Med Systems LLC
2012-06-20	Z-1791-2012	Class II	The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems…	Philips Medical Systems (Cleveland) Inc
2012-06-20	Z-1792-2012	Class II	Lipofilter 3000	MicroAire Surgical Instruments, LLC
2012-06-20	Z-1793-2012	Class II	Columbus Tibia Plateau	Aesculap Implant Systems
2012-06-20	Z-1794-2012	Class II	PlasmaJet Open Surgery Handpiece	Plasma Surgical Inc.
2012-06-20	Z-1795-2012	Class II	Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft…	Integra LifeSciences Corp.
2012-06-20	Z-1796-2012	Class II	Integra Mozaik Putty 2	Integra LifeSciences Corp.
2012-06-20	Z-1797-2012	Class II	Vygon VY	Vygon Corporation
2012-06-20	Z-1798-2012	Class II	Vygon VY	Vygon Corporation
2012-06-20	Z-1799-2012	Class II	Vygon VY	Vygon Corporation
2012-06-20	Z-1800-2012	Class II	Vygon VY	Vygon Corporation
2012-06-20	Z-1801-2012	Class II	Vygon VY	Vygon Corporation
2012-06-20	Z-1802-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1803-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1804-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1805-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1806-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1807-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1808-2012	Class II	Churchill Medical Systems	Vygon Corporation
2012-06-20	Z-1809-2012	Class II	T5 Hytrel Zipper Toga	Stryker Instruments Div. of Stryker Corporation
2012-06-20	Z-1810-2012	Class II	T4-Hytrel Zipper Toga Product Usage	Stryker Instruments Div. of Stryker Corporation

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