BEUDAMED
    FDA Recall Terminated

    Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.

    Recall: Z-2036-2014 · Initiated June 30, 2014

    Recall

    Recall Number
    Z-2036-2014
    Event Number
    68696
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2014
    Posted
    July 10, 2014
    Terminated
    July 1, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.

    Reason

    STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.

    Action

    Customers will be notified via onsite visits by STERIS Field Service Technicians to each affected Customer site. These visits will be documented and monitored until completion.

    Distribution

    US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.

    Quantity

    37