Class 3 Device Recall GentleTouch System Postoperative Kit

• Date Initiated by Firm: March 07, 2008
• Date Posted: July 02, 2008
• Recall Status: Terminated on October 21, 2008
• Recall Number: Z-1314-2008
• Recall Event ID: 47210
• Product Classification: Ostomy pouch and accessories - Product Code EXB
• Product: GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
• Code Information: Lot Numbers: 7G29699, 7G30740, 7G31418, 7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and 8A37099 are also affected, however they have not been distirbuted.
• Recalling Firm/ Manufacturer: ConvaTec; 200 Headquarters Park Dr; Skillman NJ 08558-2624
• For Additional Information Contact: Karen Krenta; 732-904-2071
• Manufacturer Reason for Recall: Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."
• FDA Determined Cause: Labeling mix-ups
• Action: Consignees were notified by an Urgent Product Recall letter sent on 3/7/08. The letter instructed users to return any unused affected product to the recalling firm for a credit. For additional information, contact 1-800-422-8811.
• Quantity in Commerce: 9,299 units
• Distribution: Worldwide Distribution including USA and 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.