BEUDAMED
    FDA Recall Open, Classified

    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

    Recall: Z-0090-2023 · Initiated September 15, 2022

    Recall

    Recall Number
    Z-0090-2023
    Event Number
    90850
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    September 15, 2022
    Posted
    October 14, 2022
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

    Reason

    The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

    Action

    On September 15, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine the product subject to recall. Once customers have returned the completed acknowledgement form to B. Braun Medical Inc., a Customer Support representative will contact the customer with instructions on returning impacted cases. The firm will provide credit and/or replacement of the product based on the customer's needs. For questions, please contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.

    Distribution

    Distribution US nationwide, Canada and Saudi Arabia.

    Quantity

    354,200 US; 1,800 OUS