BEUDAMED
    FDA Enforcement Class II Ongoing

    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

    Recall: Z-1118-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1118-2026
    Event ID
    98128
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2026
    Initiation Date
    December 15, 2025
    Classification Date
    January 16, 2026
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835, United States

    Description

    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

    Reason

    Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

    Code Info

    400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0

    Distribution

    Worldwide distribution - US Nationwide and the country of Philippines.