BEUDAMED
    FDA Enforcement Class III 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 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2036-2014
    Event ID
    68696
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    July 16, 2014
    Initiation Date
    June 30, 2014
    Classification Date
    July 10, 2014
    Termination Date
    July 1, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    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.

    Code Info

    Serial Number Range: 3632511020 - 3613214010

    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