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Open, Classified

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

FDA Recall Z-3263-2024 · Posted 2024-09-25

Recalling FirmT.G. Eakin Limited
Recall StatusOpen, Classified
Product CodeEXE
Date Initiated2024-08-08
Product Quantity35,400 cartons of 20 individually packaged seals

Reason for Recall

On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

Firm 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.

Root Cause

Process control

Distribution Pattern

US: KY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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