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U.S. Department of Health and Human Services

Class 1 Device Recall Cook Central Venous Catheter Tray, Double Lumen Polyurethane

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  Class 1 Device Recall Cook Central Venous Catheter Tray, Double Lumen Polyurethane 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-1100-2011
Recall Event ID 57663
510(K)Number K081113  
Product Classification Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
Product Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC-CCT, G26932, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Code Information Part Number: C-UDLMY-401J-RSC-CCT; Global Part Number G26932;    Lots: F2322847, F2328196, F2341763, F2349570, F2359449, F2365678, F2366174, F2366175, F2366176, F2367620, F2368180, F2368181, F2368836, F2369650, F2369814, F2369815 and F2370815 
Recalling Firm/
Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Rita A. Harden
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.