BEUDAMED
    FDA Enforcement Class II Ongoing

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

    Recall: Z-1733-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1733-2025
    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

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

    Reason

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

    Code Info

    Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171

    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

    100 systems