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U.S. Department of Health and Human Services

Class 1 Device Recall Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen

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 Class 1 Recall
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on June 21, 2011
Recall Number Z-1145-2011
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/ 15cm, C-UTLMY-701J-ABRM-HC-FST-A-RD, G44126, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-ABRM-HC-FST-A-RD, Global part number G44126 Lot number: 2241830, 2241946, 2241947, 2244225, 2244835, 2244836, 2244837, 2244839, 2245830, 2253342, 2255605, 2255607, 2255738, 2255739, 2266266, 2267178, 2267969, 2268001, 2275493, 2276215, 2276880, 2276913, 2282406, 2282407, 2282422, 2282423, 2301416, 2301420, 2302127, 2304966, 2305905, 2307487, 2309428, 2313825, 2314047, 2315396, 2315399, 2318757, 2318842, 2321308, 2322431, 2322484, 2325091, 2326801, 2328402, 2328536, 2332350, 2335175, 2336043 and 2282407X
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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