Class 2 Device Recall Cook Zilver Biliary Stent

• Date Initiated by Firm: September 21, 2006
• Date Posted: October 28, 2006
• Recall Status: Terminated on April 04, 2007
• Recall Number: Z-0080-2007
• Recall Event ID: 36391
• 510(K)Number: K051124
• Product Classification: Biliary Stent - Product Code FGE
• Product: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
• Code Information: Lot 1722922.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 800-346-2686
• Manufacturer Reason for Recall: The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
• FDA Determined Cause: Other
• Action: Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.
• Quantity in Commerce: 5
• Distribution: Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of 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 and Original Applicant = COOK, INC.