BEUDAMED
    FDA Enforcement Class II Ongoing

    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

    Recall: Z-1736-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1736-2025
    Event ID
    96622
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Galt Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2025
    Initiation Date
    March 27, 2025
    Classification Date
    May 7, 2025
    Address
    2220 Merritt Dr, N/A, Garland, TX, 75041-6137, United States

    Description

    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

    Reason

    Due to a potential open seal in the sterile barrier packaging.

    Code Info

    Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

    Quantity

    200 needles