Recall Z-1314-2008
ConvaTec · initiated March 7, 2008
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.
Codes / lots: 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.
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 taken
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.
Details
- Recall number
- Z-1314-2008
- Initiated
- March 7, 2008
- Posted by FDA
- July 2, 2008
- Terminated
- October 21, 2008
- Product code
- EXB – Collector, Ostomy
- Quantity
- 9,299 units
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Recalling firm
- ConvaTec, Skillman, NJ