BEUDAMED
    FDA Enforcement Class II Terminated

    AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    Recall: Z-0478-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0478-2014
    Event ID
    66874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2013
    Initiation Date
    October 18, 2013
    Classification Date
    December 10, 2013
    Termination Date
    May 13, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    Reason

    The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.

    Code Info

    Serial Number Range: 030061103 - 0535531220

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.

    Quantity

    936 units