BEUDAMED
    FDA Recall Open, Classified

    Spectrum IQ Infusion Pump, Product Code 3570009

    Recall: Z-2415-2025 · Initiated July 14, 2025

    Recall

    Recall Number
    Z-2415-2025
    Event Number
    97335
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 14, 2025
    Posted
    August 22, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Spectrum IQ Infusion Pump, Product Code 3570009

    Reason

    Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

    Action

    Customers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST

    Distribution

    US distribution to states of: AZ, FL

    Quantity

    6 units