FDAClass IIJuly 1, 2020

BioPince Full Core Biopsy Instrument 16ga x 15cm recall: Labeling Error

BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic…

Why was BioPince Full Core Biopsy Instrument 16ga x 15cm recalled?

Incorrect product labeling.

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?

Lot No.: 11277175; Model # 370-1580-01, 16ga x 15cm, for use with Optional Co-axial Needle MCXS1615BP

Product
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic…
Recalling firm
Argon Medical Devices, Inc
Quantity
165 units in U.S. and 330 units Internationally
Distribution
Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada.
Recall date
July 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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