Class 2 Device Recall Zilver

• Date Initiated by Firm: October 24, 2005
• Date Posted: January 13, 2006
• Recall Status: Terminated on April 10, 2006
• Recall Number: Z-0391-06
• Recall Event ID: 34162
• 510(K)Number: K051124
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60.
• Code Information: Lot 1544171.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 800-468-0489
• Manufacturer Reason for Recall: The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
• FDA Determined Cause: Other
• Action: Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.
• Quantity in Commerce: 9
• Distribution: Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = FGE