FDA Recall
Open, Classified
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Recall: Z-3263-2024
·
Initiated August 8, 2024
Recall
- Recall Number
- Z-3263-2024
- Event Number
- 95241
- Firm
- T.G. Eakin Limited
- FEI Number
- 1000339531
- Product Code
- EXE
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 8, 2024
- Posted
- September 25, 2024
- Address
- 15 Ballystockart Road, Comber Ireland
Description
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Reason
On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
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.
Distribution
US: KY
Quantity
35,400 cartons of 20 individually packaged seals