Class 3 Device Recall Quantum TTC Biliary Balloon Dilator

• Date Initiated by Firm: September 15, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on April 08, 2004
• Recall Number: Z-1292-03
• Recall Event ID: 27261
• 510(K)Number: K935094
• Product Classification: Dilator, Esophageal - Product Code KNQ
• Product: Quantum TTC Biliary Balloon Dilator
• Code Information: W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc; 4900 Bethania Station Rd; & 5951 Grassy Creek Blvd.; Winston-Salem NC 27105
• For Additional Information Contact: Jessica Hughes; 336-744-0157
• Manufacturer Reason for Recall: The product was labeled 'esophageal', but contained a 'biliary' ballon
• FDA Determined Cause: Other
• Action: The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.
• Quantity in Commerce: 127 devices
• Distribution: Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary,
• 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