Class 2 Device Recall

• Date Initiated by Firm: June 10, 2004
• Date Posted: July 27, 2004
• Recall Status: Terminated on November 01, 2004
• Recall Number: Z-1164-04
• Recall Event ID: 29300
• PMA Number: P020018
• Product Classification: System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
• 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 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74.
• Code Information: Lots F1545880, F1545881, F1555822, F1556920, F1560071 and F1560072.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• 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: 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: 6
• Distribution: Nationwide, Canada, Denmark and Japan.
• Total Product Life Cycle: TPLC 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 Database: PMAs with Product Code = MIH