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Class 2 Device Recall |
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Date Initiated by Firm |
June 10, 2004 |
Date Posted |
July 27, 2004 |
Recall Status1 |
Terminated 3 on November 01, 2004 |
Recall Number |
Z-1165-04 |
Recall Event ID |
29300 |
PMA Number |
P020018 |
Product Classification |
System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
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Product |
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 88mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-88. |
Code Information |
Lots 1349235, F1548657, F1545296, F1552607, F1548658, F1552608, F1552609, F1552610, F1549743, F1549241, F1560040, F1560039, F1560041, 1349236 and 1349237. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Customer Relations 800-457-4500
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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.
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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 |
15 |
Distribution |
Nationwide, Canada, Denmark and Japan. |
Total Product Life Cycle |
TPLC Device Report
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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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PMA Database |
PMAs with Product Code = MIH and Original Applicant = COOK, INC.
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