BEUDAMED
    FDA Enforcement Class I Terminated

    Dose IQ Safety Software used with Spectrum IQ Infusion Pump

    Recall: Z-2165-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2165-2021
    Event ID
    88246
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 7, 2021
    Classification Date
    August 11, 2021
    Termination Date
    June 20, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Dose IQ Safety Software used with Spectrum IQ Infusion Pump

    Reason

    Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

    Code Info

    Software version: All libraries initially created with version 9.0.x

    Distribution

    US Nationwide Distribution.

    Quantity

    61 units