Z-3263-2024Class III

eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

Name: Z-3263-2024 eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Creator: T.G. Eakin Limited
Published: 2024-08-08
License: https://open.fda.gov/license/

T.G. Eakin, Ltd. / initiated 2024-08-08 / Open, Classified / root cause: manufacturing process

FDA source

T.G. Eakin Limited began a recall of eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal on 2024-08-08. FDA classified it as Class III and gives the reason as "On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3263-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-09-25
Recalling firm: T.G. Eakin, Ltd.
Product: eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Product code: EXE Protector, Ostomy
Reason for recall: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
Root cause tag: manufacturing process
FDA 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 in commerce: 35,400 cartons of 20 individually packaged seals
Distribution: US: KY
Product codes and lots: UDI/DI 00768455108732, Lot number 109357C553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3263-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3263-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25

Product code EXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)