RECALLS AND FIELD CORRECTIONS 9

RECALLS AND FIELD CORRECTIONS 9 - Enforcement Report for...

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Enforcement Report for October 6, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I ___________________________________ PRODUCT Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog number: 7CBD10. Recall # Z-2425-2010 CODE Lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857 RECALLING FIRM/MANUFACTURER Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by fax, e-mail and letter on July 2, 2010. Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing. REASON Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. VOLUME OF PRODUCT IN COMMERCE 338 units DISTRIBUTION Nationwide, Canada, Taiwan and to Integra, Australia RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments within the Product Effect. Recall # Z-2423-2010 CODE Serial number range of B01060900055 through B01090100414R0, excluding B01081100388R0, B01081100389R0, B01081200396R0, B01081200402R0, B01081200403R0, B01081200404R0, B01081200406R0, B01081200408R0, B01081200410R0, B01081200411R0, B01090100412R0, B01090100413R0 RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter in May 2010. Firm initiated recall is ongoing. REASON Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur. VOLUME OF PRODUCT IN COMMERCE 228 units DISTRIBUTION
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Nationwide, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland ___________________________________ PRODUCT NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use. Catalog number RM-910. Recall # Z-2424-2010 CODE Lots 9104S911A through 9104S911E and 9104S1001A, Expiration dates November 2011 and January 2012 RECALLING FIRM/MANUFACTURER Lab Vision Corp., Fremont, CA, by letter dated March 5, 2010. Firm initiated recall is ongoing. REASON
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RECALLS AND FIELD CORRECTIONS 9 - Enforcement Report for...

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