Recall Z-1314-2008 ยท EXB Collector, Ostomy
ConvaTec
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
| Date | Jul 2, 2008 (initiated Mar 7, 2008) |
| Status | Terminated |
| Reason | Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure." |
| Root 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 | 9,299 units |
| Distribution | Worldwide Distribution including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.