BEUDAMED
    FDA Enforcement Class II 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 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1195-2017
    Event ID
    76292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    January 18, 2017
    Classification Date
    February 13, 2017
    Termination Date
    May 17, 2017
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    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.

    Code Info

    lots: 11157523, 11158179, 11158180, 11159101, 11159729

    Distribution

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

    Quantity

    772 boxes