FDAClass IINovember 2, 2022

ConvaTec Esteem+ Durahesive Plus recall

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or…

Why was ConvaTec Esteem+ Durahesive Plus recalled?

impaired functionality of the release liner

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: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m

Product
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or…
Recalling firm
ConvaTec, Inc
Quantity
5284 units
Distribution
US Nationwide distribution.
Recall date
November 2, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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