BEUDAMED
    FDA Enforcement Class II Ongoing

    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

    Recall: Z-1732-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1732-2025
    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 Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

    Reason

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

    Code Info

    KIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062

    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

    1,400 dilators