BEUDAMED
    FDA Recall Terminated

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    Recall: Z-3124-2011 · Initiated August 11, 2011

    Recall

    Recall Number
    Z-3124-2011
    Event Number
    59752
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2011
    Posted
    September 1, 2011
    Terminated
    March 19, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    Reason

    STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.

    Action

    STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Bahrain.

    Quantity

    2,235 units