BEUDAMED
    FDA Enforcement Class I Ongoing

    BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

    Recall: Z-2179-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2179-2025
    Event ID
    97067
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2025
    Initiation Date
    July 8, 2025
    Classification Date
    August 6, 2025
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

    Reason

    Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

    Code Info

    BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

    Distribution

    US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey

    Quantity

    33,162,680 units total