BEUDAMED
    FDA Enforcement Class II Ongoing

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    Recall: Z-0965-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0965-2026
    Event ID
    98000
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2025
    Initiation Date
    November 24, 2025
    Classification Date
    December 19, 2025
    Address
    600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States

    Description

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    Reason

    For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

    Code Info

    version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.

    Distribution

    US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.

    Quantity

    7 customers