Medical device recalls Moderate risk

Argon Medical Devices, Inc recalls BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Us…

Recall date
December 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2427-2020
FDA classification
Class II
Brand / firm
Argon Medical Devices, Inc
Sold / distributed
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.

Why it was recalled

Incorrect product labeling.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.

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