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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-1216-04
Recall Event ID 29300
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
Product Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-0-KTI.
Code Information Lots F1546697, F1553352, F1559930 and F1566601. 
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 35
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.
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