BEUDAMED
    FDA Enforcement Class II Ongoing

    CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

    Recall: Z-0092-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0092-2023
    Event ID
    90850
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 15, 2022
    Classification Date
    October 14, 2022
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

    Reason

    The extension set has a high probability of potential 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.

    Code Info

    UDI-DI (GTIN): 04046964298691 Lots/Expiration Dates 61762215 15-Dec-23 61762791 22-Jan-24 61767369 26-Feb-24 61779625 7-Jun-24 61791895 11-Aug-24 61806047 4-Nov-24

    Distribution

    Distribution US nationwide, Canada and Saudi Arabia.

    Quantity

    354,200 US; 1,800 OUS