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U.S. Department of Health and Human Services

Class 1 Device Recall Central Venous Catheter Tray, Triple Lumen

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 Class 1 Recall
Central Venous Catheter Tray, Triple Lumen
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on June 21, 2011
Recall Number Z-1153-2011
Recall Event ID 57663
Premarket Notification
510(K) Number
K081113 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-ABRM-HC-FST-RD, G47833, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-RSC-ABRM-HC-FST-RD, Global part number G47833 Lot number: 2238983, 2243417, 2243419, 2243420, 2243421, 2243422, 2243433, 2243434, 2243435, 2243436, 2243437, 2243438, 2243439, 2243440, 2243441, 2243442, 2244219, 2244220, 2244221, 2244222, 2244833, 2244834, 2245777, 2245778, 2246224, 2246225, 2246226, 2246227, 2246228, 2246578, 2246579, 2246580, 2246591, 2246592, 2246738, 2246739, 2246740, 2246741, 2246742, 2246748, 2246749, 2246750, 2246751, 2246752, 2246753, 2246754, 2246760, 2246761, 2246762, 2246763, 2246764, 2246765, 2246766, 2246771, 2246772, 2246773, 2246774, 2246775, 2246776, 2246777, 2246809, 2246810, 2246811, 2246812, 2246813, 2246814, 2246815, 2246816, 2247305, 2247306, 2247307, 2247308, 2247309, 2247310, 2247311, 2247319, 2247320, 2247321, 2247322, 2247323, 2247324, 2250283, 2250284, 2252444, 2253263, 2253264, 2253265, 2253266, 2253277, 2253746, 2253747, 2254297, 2254298, 2255152, 2255599, 2255600, 2255602, 2255603, 2256793, 2256794, 2256795, 2256796, 2256797, 2256798, 2256799, 2264541, 2264542, 2264543, 2264544, 2264545, 2264546, 2264547, 2264548, 2264549, 2267160, 2267161, 2267162, 2267163, 2270308, 2270622, 2270623, 2270624, 2270625, 2270626, 2270631, 2270632, 2270633, 2272770, 2272771, 2275425, 2275426, 2275427, 2275428, 2275429, 2276851, 2276852, 2276853, 2276854, 2276858, 2276859, 2276860, 2276861, 2276862, 2276863, 2276864, 2276869, 2276870, 2276871, 2276872, 2276873, 2276874, 2276875, 2279124, 2279125, 2279133, 2279134, 2279135, 2279136, 2279137, 2279138, 2279139, 2279140, 2279141, 2279142, 2279143, 2279144, 2279145, 2279146, 2279152, 2279153, 2279154, 2279155, 2284627, 2284628, 2284632, 2286370, 2286371, 2286372, 2286373, 2286374, 2286375, 2286377, 2286378, 2286379, 2286380, 2286381, 2286382, 2286383, 2286865, 2286866, 2286867, 2286868, 2286869, 2286870, 2286871, 2286872, 2286873, 2286874, 2287299, 2287300, 2287702, 2287703, 2289367, 2289368, 2289369, 2289857, 2289858, 2289859, 2289860, 2289861, 2289862, 2289863, 2289864, 2289865, 2289866, 2289867, 2289868, 2289869, 2289870, 2289871, 2289872, 2290103, 2290104, 2290105, 2290106, 2290107, 2290108, 2290109, 2290910, 2290911, 2290912, 2290913, 2291780, 2291781, 2291782, 2291783, 2291784, 2291785, 2291786, 2294016, 2294017, 2294018, 2294019, 2294020, 2294022, 2294023, 2294024, 2294025, 2294030, 2294031, 2294032, 2294043, 2294044, 2294045, 2294046, 2294749, 2294750, 2294751, 2295486, 2296167, 2296168, 2296169, 2296190, 2296191, 2296192, 2296193, 2297509, 2297510, 2297511, 2297522, 2297523, 2297524, 2297525, 2297530, 2297531, 2297532, 2298489, 2298490, 2298497, 2298498, 2298499, 2299210, 2299217, 2299445, 2299446, 2299448, 2299449, 2299450, 2299456, 2299457, 2299458, 2299459, 2299460, 2299461, 2299462, 2301428, 2301429, 2302074, 2302075, 2302076, 2302077, 2302078, 2302079, 2302080, 2302092, 2302093, 2302094, 2302095, 2302131, 2302132, 2302133, 2303179, 2303180, 2303850, 2303851, 2303852, 2303853, 2303854, 2303855, 2305894, 2305895, 2305896, 2305897, 2305898, 2305899, 2305900, 2305913, 2305914, 2305915, 2305916, 2307479, 2307480, 2307501, 2308274, 2308275, 2308281, 2308282, 2308283, 2308284, 2308351, 2308352, 2308353, 2308354, 2309358, 2309359, 2309434, 2309435, 2309436, 2311596, 2311597, 2311598, 2312061, 2312062, 2312966, 2312988, 2312989, 2312990, 2313811, 2313812, 2313813, 2315348, 2315349, 2315350, 2315421, 2315422, 2315423, 2315424, 2317372, 2317393, 2317394, 2317395, 2317459, 2317460, 2317461, 2317462, 2319574, 2319596, 2319597, 2319598, 2319599, 2320316, 2321456, 2323367, 2324269, 2324270, 2326712, 2326713, 2326793, 2327441, 2327442, 2327497, 2327498, 2327499, 2327500, 2328416, 2328541, 2328542, 2328543, 2329812, 2330570, 2330571, 2331476, 2331477, 2332356, 2332357, 2332358, 2334842, 2334843, 2334844, 2335179, 2335180, 2335181, 2335182, 2335183, 2335184, 2335185, 2337164, 2246225X, 2270625X, 2289858X, 2289863X, 2289866X, 2294022X and 2294023X.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
For Additional Information Contact Rita A. Harden
812-339-2235
Manufacturer Reason
for Recall
Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Quantity in Commerce 51,473 total kits/trays
Distribution Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.
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