BEUDAMED
    FDA Enforcement Class I Ongoing

    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

    Recall: Z-2376-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2376-2021
    Event ID
    88455
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 15, 2021
    Initiation Date
    August 6, 2021
    Classification Date
    September 3, 2021
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

    Reason

    There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

    Code Info

    Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230 Model H-1129: Product Code H-1129

    Distribution

    US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa

    Quantity

    913