BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2678-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2678-2016
    Event ID
    74927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    August 11, 2016
    Classification Date
    August 26, 2016
    Termination Date
    June 13, 2017
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    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.

    Code Info

    Lot Number 40259236

    Distribution

    Distributed in LA and TN.

    Quantity

    26 units