| Class 2 Device Recall | |
Date Initiated by Firm | June 10, 2004 |
Date Posted | July 27, 2004 |
Recall Status1 |
Terminated 3 on November 01, 2004 |
Recall Number | Z-1198-04 |
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 Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-18-71. |
Code Information |
Lots F1564404, F1564405, F1569313, F1569314, F1573013, F1573014, F1573017, F1564406, F1564407, F1566706, F1566707, F1566708, F1569258, F1569259, F1565697, F1565698, F1565699, F1565696, F1569260, F1569312, F1566709, F1573015, F1573016, F1573018, F1573019, F1573020, F1567298, F1567299, F1578450, F1578377, F1575346, F1578378, F1575347, F1578379, F1575348, F1575208 and F1575209. |
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 | 37 |
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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