BEUDAMED
    FDA Enforcement Class II Ongoing

    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

    Recall: Z-1737-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1737-2025
    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 Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

    Reason

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

    Code Info

    Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447

    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

    490 units