Date Initiated by Firm | December 20, 2004 |
Date Posted | February 03, 2005 |
Recall Status1 |
Terminated 3 on December 02, 2005 |
Recall Number | Z-0504-05 |
Recall Event ID |
30721 |
PMA Number | P020018 |
Product Classification |
System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
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Product | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=126mm, C=96mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-96. |
Code Information |
All units distributed on or before 12/17/04. |
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 | The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft. |
FDA Determined Cause 2 | Other |
Action | Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm. |
Distribution | Nationwide and Canada. |
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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