BEUDAMED
    FDA Enforcement Class II Ongoing

    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

    Recall: Z-0130-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0130-2024
    Event ID
    93074
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    September 26, 2023
    Classification Date
    November 3, 2023
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

    Reason

    Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

    Code Info

    UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

    Quantity

    32,000