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U.S. Department of Health and Human Services

Class 1 Device Recall Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter

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 Class 1 Recall
Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on June 21, 2011
Recall Number Z-1192-2011
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/ 20 cm Power Injectable, C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-A-RD, G49804, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-A-RD, Global part number G49804. Lot numbers: 2245779; 2246581; 2246582; 2246743; 2246755; 2246767; 2246768; 2246778; 2246817; 2247302; 2247312; 2254299; 2254300 ; 2255153 ;2255601; 2262104; 2262107; 2262109; ;2262110;2262115; 2262116; 2263203; 2263204; 2263205; 2263206; 2263207; 2263208; 2263209; 2263210; 2263211; 2263212; 2276847; 2276848; 2276849; 2276850; 2276855; 2276856; 2276857; 2276865; 2276866; 2279147; 2279148; 2279149; 2280748; 2281673; 2287298; 2287301; 2287701; 2287704; 2289355; 2289357; 2289358; 2289359; 2289370; 2289371; 2289873; 2290110; 2290111; 2291743; 2291744; 2291745; 2291746; 2291747; 2291748; 2291749; 2291755; 2291763; 2291764; 2291787; 2291788; 2293493; 2294752; 2294783; 2296170; 2296194; 2296821; 2296832; 2297512; 2297526; 2297533; 2298500;; 2299447; 2299451; 2299463; 2299464; 2302081; 2302096; 2302134; 2304967; 2304972; 2305901; 2305902; 2305917; 2309321; 2309334; 2309339; 2309360; 2309437; 2311577; 2311578; 2311599; 2312951; 2312953; 2312956; 2312967; 2312991; 2313814; 2315320; 2315330; 2315351; 2315352; 2315425; 2315943; 2315944; 2315951; 2316749; 2316755; 2317373; 2317374; 2317396; 2317397; 2319575; 2319600; 2320292; 2320293; 2320301; 2320302; 2320317; 2331453; 2331462; 2331478; 2332359; 2335186; 2255153X; 2275441.
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 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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