BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1723-2025 · Initiated April 7, 2025

    Recall

    Recall Number
    Z-1723-2025
    Event Number
    96649
    Firm
    Ambu Inc.
    FEI Number
    1121788
    Product Code
    EOQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 7, 2025
    Posted
    May 6, 2025
    Address
    6721 Columbia Gateway Dr, Ste 200, Columbia, MD, 21046-3380

    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.

    Action

    Ambu notified sales representative first on 04/07/2025 with an "Urgent Field Safety Notice" letter and they are instructed to visit the affected accounts to notify them of the recall. The letter instructs customers to identify and quarantine any affected units on hand, to arrange for the return of affected units or destroy them on site, and to complete and return the response form.

    Distribution

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

    Quantity

    160 units