eakin Cohesive seal, small, Model Number 839002, ostomy… recallZ-3263-2024 · T.G. Eakin Limited · initiated Aug 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from T.G. Eakin Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3263-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2024
- Posted by the FDA
- Sep 25, 2024
- Recalling firm
- T.G. Eakin Limited
- Quantity
- 35,400 cartons of 20 individually packaged seals
- Product code
- EXE
- Distribution
- US: KY
Product description
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Code information (models, lots, serial numbers)
UDI/DI 00768455108732, Lot number 109357C553
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Eakin 839002T.G. Eakin Limited · Protector, Ostomy1 recall20 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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