BEUDAMED
    FDA Enforcement Class II Terminated

    AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

    Recall: Z-0603-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0603-2016
    Event ID
    72825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 20, 2015
    Classification Date
    January 6, 2016
    Termination Date
    October 27, 2016
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

    Reason

    The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.

    Code Info

    Serial #'s: 0428014026 - 0432115014

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.

    Quantity

    2,319 units