BEUDAMED
    FDA Enforcement Class II Terminated

    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

    Recall: Z-0107-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0107-2019
    Event ID
    81158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 24, 2018
    Initiation Date
    September 18, 2018
    Classification Date
    October 12, 2018
    Termination Date
    August 19, 2020
    Address
    711 Park Ave, N/A, Medina, NY, 14103-1036, United States

    Description

    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

    Reason

    If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

    Code Info

    UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

    Distribution

    NJ

    Quantity

    354 units