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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 Device Recall Central Venous Catheter Tray, Triple Lumen see related information
Date Initiated by Firm October 04, 2010
Date Posted February 23, 2011
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-1151-2011
Recall Event ID 57663
510(K)Number K081113  
Product Classification Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
Product Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMY-701J-ABRM-HC-FST-RD, G47831, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-ABRM-HC-FST-RD, Global part number G47831 Lot number: 2238150, 2238157, 2240345, 2241829, 2241831, 2241867, 2241944, 2241945, 2241948, 2245787, 2245831, 2246217, 2247688, 2248272, 2248321, 2248943, 2248944, 2250303, 2251986, 2251998, 2252008, 2253301, 2253343, 2255616, 2255740, 2256110, 2256160, 2256167, 2257546, 2259341, 2259414, 2264558, 2265389, 2265396, 2266276, 2268074, 2268926, 2270316, 2270318, 2270682, 2273807, 2275454, 2275455, 2275469, 2276890, 2277907, 2278555, 2278560, 2278670, 2279209, 2281658, 2281659, 2282539, 2283327, 2283328, 2286942, 2291834, 2291835, 2291836, 2291837, 2291839, 2291840, 2292792, 2292794, 2292797, 2294041, 2294603, 2294707, 2294715, 2294748, 2296188, 2297830, 2299453, 2300861, 2300862, 2303847, 2304440, 2304444, 2304445, 2308280, 2308350, 2309429, 2311575, 2311593, 2312986, 2315329, 2315344, 2315345, 2315938, 2315940, 2315950, 2316754, 2317390, 2317452, 2321297, 2321298, 2323347, 2323353, 2325092, 2326690, 2326710, 2327438, 2328414, 2328537, 2331452, 2331459, 2332351, 2334841, 2335176, 2337152 and 2282539X.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = COOK, INC.
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