BEUDAMED
    FDA Recall Terminated

    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

    Recall: Z-0915-2013 · Initiated February 12, 2013

    Recall

    Recall Number
    Z-0915-2013
    Event Number
    64440
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 12, 2013
    Posted
    March 6, 2013
    Terminated
    December 5, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

    Reason

    The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.

    Action

    Steris Corporation initiated their recall on February 12, 2013. They will notify customers via onsite visits by STERIS Field Service Technicians to each affected Customer site. For further questions, please call (440) 392-7601.

    Distribution

    Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.

    Quantity

    395 Units