BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2427-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2427-2020
    Event ID
    85426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    December 2, 2019
    Classification Date
    June 25, 2020
    Termination Date
    November 9, 2022
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    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.

    Reason

    Incorrect product labeling.

    Code Info

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

    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.

    Quantity

    165 units in U.S. and 330 units Internationally