BEUDAMED
    FDA Recall Open, Classified

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    Recall: Z-0348-2025 · Initiated October 2, 2024

    Recall

    Recall Number
    Z-0348-2025
    Event Number
    95505
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 2, 2024
    Posted
    November 8, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    Reason

    The door on the Spectrum IQ Infusion pump may not be able to fully close.

    Action

    Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.

    Distribution

    GA, ID

    Quantity

    8 units