Class 2 Device Recall

• Date Initiated by Firm: June 09, 2005
• Date Posted: June 28, 2005
• Recall Status: Terminated on September 21, 2005
• Recall Number: Z-0940-05
• Recall Event ID: 32422
• 510(K)Number: K851962
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
• Code Information: Lot Number: R1698831, Labeled Reorder Number CLBS-7-12
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc; 5951 Grassy Creek Blvd; Winston Salem NC 27105-1206
• For Additional Information Contact: Sharon Miles; 336-744-0157
• Manufacturer Reason for Recall: The reorder number listed on the product label is inaccurate.
• FDA Determined Cause: Other
• Action: Consignees were notified by email/fax on 06/17/2005.
• Quantity in Commerce: 1 unit
• Distribution: Brazil, Japan & Hong Kong
• 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