BEUDAMED
    FDA Enforcement Class II Ongoing

    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

    Recall: Z-1968-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1968-2023
    Event ID
    92322
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Galt Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2023
    Initiation Date
    May 8, 2023
    Classification Date
    June 15, 2023
    Address
    2220 Merritt Dr, N/A, Garland, TX, 75041-6137, United States

    Description

    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

    Reason

    Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

    Code Info

    REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027); KIT-900-16/S22308637(1/04/2027)

    Distribution

    Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

    Quantity

    490