Class 2 Device Recall

• Date Initiated by Firm: April 21, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 17, 2004
• Recall Number: Z-0908-04
• Recall Event ID: 28905
• 510(K)Number: K851962
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Biliary Stent Introducer Set
• Code Information: Reorder (catalog) number SIS-10, Lot number W1733880
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc; 5951 Grassy Creek Blvd; Winston Salem NC 27105-1206
• For Additional Information Contact: Jessica Hughes; 336-744-0157
• Manufacturer Reason for Recall: The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
• FDA Determined Cause: Other
• Action: Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .
• Quantity in Commerce: 23 pieces
• Distribution: MO, NY, PA, Australia, Israel and England
• 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