BEUDAMED
    FDA Enforcement Class II Ongoing

    CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125

    Recall: Z-0409-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0409-2023
    Event ID
    90967
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    November 2, 2022
    Classification Date
    December 3, 2022
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125

    Reason

    BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.

    Code Info

    UDI/DI 10885403041211, ALL LOTS

    Distribution

    Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

    Quantity

    45 units