BEUDAMED
    FDA Enforcement Class II Ongoing

    Plum Duo Infusion Pump, 40002-0401

    Recall: Z-2312-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2312-2026
    Event ID
    98872
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    April 29, 2026
    Classification Date
    June 5, 2026
    Address
    600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States

    Description

    Plum Duo Infusion Pump, 40002-0401

    Reason

    Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

    Code Info

    UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3

    Distribution

    Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

    Quantity

    13,613