BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 1, 2022

    Recall

    Recall Number
    Z-0009-2023
    Event Number
    90830
    Firm
    B Braun Medical Inc
    FEI Number
    3003218564
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 1, 2022
    Posted
    October 6, 2022
    Address
    200 Boulder Dr, Breinigsville, PA, 18031-1532

    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.

    Action

    On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs.

    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