BEUDAMED
    FDA Recall Terminated

    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

    Recall: Z-2678-2016 · Initiated August 11, 2016

    Recall

    Recall Number
    Z-2678-2016
    Event Number
    74927
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 11, 2016
    Posted
    August 26, 2016
    Terminated
    June 13, 2017
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

    Reason

    The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

    Action

    DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.

    Distribution

    Distributed in LA and TN.

    Quantity

    26 units