BEUDAMED
    FDA Enforcement Class II Terminated

    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.

    Recall: Z-1105-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1105-2017
    Event ID
    76190
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    February 1, 2017
    Initiation Date
    October 25, 2016
    Classification Date
    January 26, 2017
    Termination Date
    July 25, 2017
    Address
    1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States

    Description

    NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.

    Reason

    Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.

    Code Info

    S105B0061

    Distribution

    Distribution in the foreign country of Sweden

    Quantity

    1