BEUDAMED
    FDA Enforcement Class II Ongoing

    VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

    Recall: Z-0331-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0331-2025
    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

    VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; 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 00812496011022, Lot Numbers: 62045-A8339, 62045-A8376, 62045-A8467

    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

    384 cases of 50 units