BEUDAMED
    FDA Enforcement Class II Ongoing

    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

    Recall: Z-1723-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1723-2025
    Event ID
    96649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ambu Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2025
    Initiation Date
    April 7, 2025
    Classification Date
    May 6, 2025
    Address
    6721 Columbia Gateway Dr Ste 200, N/A, Columbia, MD, 21046-3380, United States

    Description

    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

    Reason

    Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.

    Code Info

    Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.

    Quantity

    160 units