BEUDAMED
    FDA Enforcement Class II Ongoing

    Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

    Recall: Z-0009-2023 · Reported October 12, 2022

    Enforcement

    Recall Number
    Z-0009-2023
    Event ID
    90830
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2022
    Initiation Date
    September 1, 2022
    Classification Date
    October 6, 2022
    Address
    200 Boulder Dr, N/A, Breinigsville, PA, 18031-1532, United States

    Description

    Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

    Reason

    Potential for leakage at the catheter hub.

    Code Info

    UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027

    Distribution

    Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada

    Quantity

    94,000 US