BEUDAMED
    FDA Enforcement Class III Terminated

    AMSCO 400 and AMSCO C Small Steam Sterilizers

    Recall: Z-0210-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0210-2016
    Event ID
    72217
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    September 3, 2015
    Classification Date
    November 4, 2015
    Termination Date
    January 22, 2016
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    AMSCO 400 and AMSCO C Small Steam Sterilizers

    Reason

    In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.

    Code Info

    Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501

    Distribution

    US nationwide distribution.

    Quantity

    32 units