BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 13, 2026

    Recall

    Recall Number
    Z-1368-2026
    Event Number
    98306
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    January 13, 2026
    Posted
    February 13, 2026
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.

    Distribution

    States: Ohio Countries: United States

    Quantity

    5