BEUDAMED
    FDA Recall Open, Classified

    Baxter Spectrum IQ Infusion Pump, Product Code 3570009

    Recall: Z-1775-2024 · Initiated March 20, 2024

    Recall

    Recall Number
    Z-1775-2024
    Event Number
    94446
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 20, 2024
    Posted
    May 3, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter Spectrum IQ Infusion Pump, Product Code 3570009

    Reason

    One device was improperly performed testing prior to release from a Service Center.

    Action

    The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.

    Distribution

    US Nationwide distribution in the state of Massachusetts.

    Quantity

    1 pump