BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

    Recall: Z-1368-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1368-2026
    Event ID
    98306
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 25, 2026
    Initiation Date
    January 13, 2026
    Classification Date
    February 13, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A

    Reason

    Pumps were released without full testing being performed, including occlusion alarm testing.

    Code Info

    Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599

    Distribution

    States: Ohio Countries: United States

    Quantity

    5