BEUDAMED
    FDA Enforcement Class II Terminated

    Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601

    Recall: Z-2188-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2188-2015
    Event ID
    71533
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    June 18, 2015
    Classification Date
    July 21, 2015
    Termination Date
    June 23, 2016
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601

    Reason

    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

    Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707

    Distribution

    US

    Quantity

    6390 units