BEUDAMED
    FDA Recall Terminated

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    Recall: Z-2122-2012 · Initiated July 14, 2012

    Recall

    Recall Number
    Z-2122-2012
    Event Number
    62557
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 14, 2012
    Posted
    August 1, 2012
    Terminated
    June 6, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    Reason

    To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer.

    Action

    Steris Corp. sent a Urgent Field Correction Notice dated July 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To ensure users are properly operating the Reliance 130 and 130L Cart Washers a 'door close' confirmation button and a door open delay will be installed on the affected cart washer(s). A STERIS Service Representative will contact the affected facilities to arrange for STERIS to upgrade their Reliance 130 and 130L Cart Washer(s). For further information or if affected customers have any questions regarding the STERIS visit to their facility, they can contact STERIS Field Service Dispatch at 1800-333-8828

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. and the countries of : Australia, South Korea, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, UAE, United Kingdom and Canada.

    Quantity

    367