Class 2 Device Recall Quantum TTC Biliary Balloon Dilation Catheter

• Date Initiated by Firm: January 24, 2007
• Date Posted: February 22, 2007
• Recall Status: Terminated on July 26, 2012
• Recall Number: Z-0520-2007
• Recall Event ID: 37213
• 510(K)Number: K935094
• Product Classification: Balloon Dilator - Product Code KNQ
• Product: Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
• Code Information: Order number QBD-10X3, Lot number W2287708
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Cook Endoscopy; 5951 Grassy Creek Blvd; Winston Salem NC 27105-1206
• For Additional Information Contact: Sharon Miles; 336-767-2657 Ext. 6325
• Manufacturer Reason for Recall: The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
• FDA Determined Cause: Other
• Action: Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
• Quantity in Commerce: 12 units
• Distribution: Worldwide, including NY and TX in USA, Australia, Canada and India.
• 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 = KNQ