BEUDAMED
    FDA Enforcement Class II Terminated

    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments

    Recall: Z-1979-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1979-2012
    Event ID
    62389
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    June 27, 2012
    Classification Date
    July 9, 2012
    Termination Date
    February 20, 2014
    Address
    160 Weymouth St, Rockland, MA, 02370-1136, United States

    Description

    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments

    Reason

    HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

    Code Info

    All serial numbers

    Distribution

    US Nationwide Distribution

    Quantity

    2247 units