BEUDAMED
    FDA Enforcement Class III Terminated

    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

    Recall: Z-1145-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1145-2017
    Event ID
    75557
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    October 31, 2016
    Classification Date
    February 7, 2017
    Termination Date
    November 27, 2017
    Address
    1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States

    Description

    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

    Reason

    HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

    Code Info

    S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.

    Distribution

    Internationally to Finland

    Quantity

    33