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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-1191-2011
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/ 15 cm Power Injectable, C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, G49803, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part number: C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, Global part number G49803. Lot numbers: 2240346; 2241834; 2245786; 2248322; 2249284; 2251999; 2253344; 2255176; 2255741; 2259342; 2268075; 2269800; 2276914; 2277908; 2281660; 2282559; 2285525; 2286943; 2291838; 2293485; 2294042; 2297529; 2299454; 2303178; 2306599; 2309430; 2311594; 2315346; 2316748; 2317453; 2318707; 2318718; 2318843; 2321268; 2321271; 2321282; 2321283; 2321299; 2325081; 2325083; 2325094; 2329811; 2331460; 2335177.
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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