BEUDAMED
    FDA Recall Terminated

    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

    Recall: Z-1195-2017 · Initiated January 18, 2017

    Recall

    Recall Number
    Z-1195-2017
    Event Number
    76292
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    January 18, 2017
    Posted
    February 13, 2017
    Terminated
    May 17, 2017
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

    Reason

    The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

    Action

    Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

    Quantity

    772 boxes