BEUDAMED
    FDA Enforcement Class II 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 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2122-2012
    Event ID
    62557
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    August 8, 2012
    Initiation Date
    July 14, 2012
    Classification Date
    August 1, 2012
    Termination Date
    June 6, 2014
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    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.

    Code Info

    The codes for the product are Julian date-coded. They follow the following pattern: AABBBCCDDD AA is a two digit code representing the manufacturing facility number BBB is a three digit code representing the day of the year that the device was manufactured CC is a two digit code representing the Julian year that the device was manufactured DDD is a three digit code representing the number of the number of the device manufactured that day. For example, a serial number of 3606499005 indicates that the device was manufactured in facility number 36, on the 64th day of the year of 1999, and the device was the 5th device manufactured that day. The serial number ranges for the devices being recalled are: RELIANCE¿ 130: 3606499005  3626709006 RELIANCE¿ 130L: 3629299006  3628809011

    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