FDAClass IIIOctober 2, 2024

eakin Cohesive seal recall

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

Why was eakin Cohesive seal recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00768455108732, Lot number 109357C553

Product
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Recalling firm
T.G. Eakin Limited
Quantity
35,400 cartons of 20 individually packaged seals
Distribution
US: KY
Recall date
October 2, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls