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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Antimicrobial Catheter

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  Class 2 Device Recall Cook Antimicrobial Catheter see related information
Date Initiated by Firm January 02, 2007
Date Posted March 16, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0637-2007
Recall Event ID 37102
510(K)Number K950118  
Product Classification Catheter - Product Code FOZ
Product COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum¿ Glide¿ Antimicrobial Catheter with EZ--Pass¿ Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
Code Information Lots 1794998 and 1793611.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
800-346-2626
Manufacturer Reason
for Recall		 These catheters do not include the proximal sidehole as required by the specification.
FDA Determined
Cause 2		 Other
Action Consignees were notified by phone on 1/2/07 and instructed to return the product.
Quantity in Commerce 100
Distribution Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
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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