BEUDAMED
    FDA Enforcement Class II Terminated

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid 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-2335-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2335-2012
    Event ID
    62895
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    August 1, 2012
    Classification Date
    September 7, 2012
    Termination Date
    June 6, 2014
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid 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

    The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

    Code Info

    Model #: P6500, S/N 400000 through 406294

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.

    Quantity

    6,051 units