BEUDAMED
    FDA Enforcement Class II Ongoing

    Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

    Recall: Z-0342-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0342-2025
    Event ID
    95499
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    The Metrix Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2024
    Initiation Date
    October 9, 2024
    Classification Date
    November 8, 2024
    Address
    4400 Chavenelle Rd, N/A, Dubuque, IA, 52002-2655, United States

    Description

    Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

    Reason

    A limited number of IV bags have been found to leak during filling.

    Code Info

    UDI/DI 00812496011305, Lot Numbers: 68040-A8318, 68040-A8408, 68040-A8441, 68040-A8474

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.

    Quantity

    768 units