BEUDAMED
    FDA Recall 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 · Initiated October 18, 2013

    Recall

    Recall Number
    Z-0478-2014
    Event Number
    66874
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 18, 2013
    Posted
    December 11, 2013
    Terminated
    May 13, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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.

    Action

    Steris sent an Urgent Voluntary Field Correction Notice letter dated October 18, 2013 to their customers. The letter identified the affected product, problem, and actions to be taken. The letter informed customers that a Steris Service Representative will contact affected facility to arrange for Steris to upgrade the Transfer Carriage(s). For questions contact Steris Field Service Dispatch at 1-800-333-8828.

    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