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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 10, 2004
Date PostedJuly 27, 2004
Recall Status1 Terminated 3 on November 01, 2004
Recall NumberZ-1188-04
Recall Event ID 29300
PMA NumberP020018 
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
ProductCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-14-37.
Code Information Lots F1559043, F1559044, F1559045, F1559046, F1559047, F1564157, F1564158, F1564159, F1565733, F1565734, F1565735, F1564343, F1564344, F1569241, F1569242, F1570167, F1570168, F1571038, F1571039, F1571040, F1572951, F1572952, F1575289, F1575290, F1575291, F1575192, F1575193, F1575194, F1569243, F1569309, F1571037, F1570166, F1572950, F1576379, F1576381 and F1576382. 
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCustomer 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
ActionThe 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 Commerce36
DistributionNationwide, Canada, Denmark and Japan.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MIH
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