RECALLS AND FIELD CORRECTIONS 4

RECALLS AND FIELD CORRECTIONS 4 - Michael medlin END OF...

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Michael medlin END OF ENFORCEMENT REPORT FOR SEPTEMBER 1, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT 1) Fresenius 2008H Dialysate Delivery Machine, Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished). Recall # Z-2224-2010; 2) Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished). Recall # Z-2225-2010; 3) Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Catalog Numbers G047-80101 and RTLG047-80101. Recall # Z-2226-2010; 4) Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers. Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers). Recall # Z-2227-2010 CODE No lot numbers RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius Medical Care North America, Waltham, MA, by letter on June 28, 2010. Manufacturer: Fresenius USA, Inc., Walnut Creek, CA. Firm initiated recall is ongoing. REASON Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. VOLUME OF PRODUCT IN COMMERCE 72,142 units DISTRIBUTION Nationwide and Internationally ___________________________________ PRODUCT AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. Model numbers: 10094139, 5904466, 7555365. Recall # Z-2233-2010 CODE Serial numbers: 20136, 157435, 20205, 57089, 20334, 20114, 57077, 157458, 20052, 20303, 20343, 20016, 157136, 20208, 20238, 20242, 157436, 57144, 57189, 20322, 20295, 20081, 157448, 20209, 157165, 20254, 20170, 20282, 20076, 157168, 20050, 157213, 20363, 20179, 57035, 157164, 157156, 20202, 20338, 57188, 20348, 20172, 20183, 57073, 20264, 57016, 20325, 20143, 20367, 20258, 57009, 20182, 20175, 157169, 20056, 57004, 20082, 20037, 20053, 157139, 57187, 58702, 20250, 20313,
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20100, 20207, 20230, 157146, 20157, 157476, 20249, 57204, 20140, 57111, 20181, 20281, 57171, 20033, 20074, 20165, 57113, 20243, 20178, 57193, 20188, 20339, 57117, 20141, 57041, 57072, 57008, 157414, 20321, 157215, 57198, 57054, 57155, 20097, 20003, 20015, 20233, 20220, 20265, 57098, 57124, 57116, 57045, 157184, 20185, 57156, 57076, 57105, 58701, 20086, 20087, 20217, 157409, 20102, 57012, 57201, 20180, 20294, 157466, 157442, 20129, 157449, 20171, 57024, 57183, 157438, 157440 RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on July 13, 2010. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
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This note was uploaded on 07/10/2011 for the course ECON 101 taught by Professor Tuner during the Spring '11 term at Solano Community College.

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RECALLS AND FIELD CORRECTIONS 4 - Michael medlin END OF...

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