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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 10, 2004
Date Posted July 27, 2004
Recall Status1 Terminated 3 on November 01, 2004
Recall Number Z-1160-04
Recall Event ID 29300
PMA Number P020018 
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
Product Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.
Code Information Lots 1356524, 1356532, 1356519, 1356525, 1356523, 1356522 and 1356529. 
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Customer Relations
800-457-4500
Manufacturer Reason
for Recall		 Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
FDA Determined
Cause 2		 Other
Action The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
Quantity in Commerce 7
Distribution Nationwide, Canada, Denmark and Japan.
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.
PMA Database PMAs with Product Code = MIH and Original Applicant = COOK, INC.
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