FDA Medical Device Recalls (openFDA)
T.G. Eakin Limited: eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
- Recall number
- Z-3263-2024
- Recalling firm
- T.G. Eakin Limited
- Product
- eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
- Status
- Open, Classified
- Initiated
- 2024-08-08
- Posted
- 2024-09-25
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI/DI 00768455108732, Lot number 109357C553
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXE
- Firm FEI
- 1000339531
- Firm city
- Comber
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28