FDAClass IIINovember 5, 2014

Biatain Super Non-Adhesive recall: Labeling Error

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily…

Why was Biatain Super Non-Adhesive recalled?

Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

4201931

Product
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily…
Recalling firm
Coloplast Manufacturing US, LLC
Quantity
6
Distribution
US Distribution to MO and RI.
Recall date
November 5, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
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