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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 [email protected] 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. REASON The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion. VOLUME OF PRODUCT IN COMMERCE 131 units DISTRIBUTION Nationwide ___________________________________ PRODUCT 3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8, Left, Part # 333-01-108. Recall # Z-2244- 2010 CODE Lot number: A1000003 RECALLING FIRM/MANUFACTURER Encore Medical, LP, Austin, TX, by letter on June 28, 2010. Firm initiated recall is ongoing. REASON One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. VOLUME OF PRODUCT IN COMMERCE 18 units DISTRIBUTION FL, MO, and Italy ___________________________________ PRODUCT 1) Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Recall # Z-2271-2010; 2) Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Recall # Z-2272-2010; 3) Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters
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