BEUDAMED
    FDA Recall Terminated

    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.

    Recall: Z-2831-2011 · Initiated June 27, 2011

    Recall

    Recall Number
    Z-2831-2011
    Event Number
    59184
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    NNY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2011
    Posted
    July 15, 2011
    Terminated
    March 20, 2012
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.

    Reason

    The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.

    Action

    Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.

    Distribution

    Nationwide Distribution (USA) including the states of FL, GA, OH and SC.

    Quantity

    6880 units (total for both products)