Date Initiated by Firm | June 10, 2004 |
Date Posted | July 27, 2004 |
Recall Status1 |
Terminated 3 on November 01, 2004 |
Recall Number | Z-1168-04 |
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 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 132mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-24-132. |
Code Information |
Lot F1571627. |
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 |
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 | 1 |
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
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