FDAClass IIIApril 24, 2019

BIOPHEN LMWH Control C4 recall

BIOPHEN LMWH Control C4, REF 224201

Why was BIOPHEN LMWH Control C4 recalled?

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

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?

Lots F1701555P4

Product
BIOPHEN LMWH Control C4, REF 224201
Recalling firm
Aniara Diagnostica LLC
Quantity
3 units
Distribution
Distributed to accounts in MI and PA.
Recall date
April 24, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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