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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-1170-04
Recall Event ID 29300
PMA NumberP020018 
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
ProductCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR;Catalog no. TFB-24-88.
Code Information Lots 1364666, 1353961, 1367854, F1537400, F1537401, F1538639, F1538638, F1537402, F1528735, F1541861, F1539270, F1541860, F1541862, F1545882, F1545883, F1543306, F1543307, F1542762, F1542763, F1542764, F1542765, F1541863, F1541864, F1550301, F1550302, F1550303, F1545884, F1556701, F1556702, F1546890, F1548094, F1548095, F1554818, F1556700, F1565060, F1565058, F1565059, F1567223, F1567224, F1567225, F1572841, F1572842, F1572843, F1572844, F1575176, F1575177, F1575115, F1575116, F1575117, 1353962, 1360730, 1363309 and 1343884.
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 Commerce53
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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