BEUDAMED
    FDA Enforcement Class II Ongoing

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    Recall: Z-1763-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1763-2025
    Event ID
    96771
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    May 2, 2025
    Classification Date
    May 14, 2025
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835, United States

    Description

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    Reason

    Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

    Code Info

    LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

    Quantity

    12 US, 3 OUS