BEUDAMED
    FDA Recall Terminated

    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

    Recall: Z-2189-2015 · Initiated June 18, 2015

    Recall

    Recall Number
    Z-2189-2015
    Event Number
    71533
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 18, 2015
    Posted
    July 21, 2015
    Terminated
    June 23, 2016
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

    Reason

    Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

    Action

    The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.

    Distribution

    US

    Quantity

    10290 units