Recall Z-3263-2024 ยท EXE Protector, Ostomy
T.G. Eakin Limited
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
| Date | Sep 25, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| Reason | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. |
| Root cause | Process control |
| Action | Eakin notified its sole consignee (a distributor) of the recall via email on 08/08/2024. The notice explained the issue and requested that any affected product be discarded. The consignee notified its customers on 08/14/2024 of the recall, requesting that the affected product be discarded. For questions, please contact: In USA, Convatec Inc. on 1-800-422-8811. In Canada, Convatec Canada Limited on 1-800-465-6302. |
| Quantity | 35,400 cartons of 20 individually packaged seals |
| Distribution | US: KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.