BEUDAMED
    FDA Enforcement Class II Ongoing

    Aeris Balloon Dilation Catheter

    Recall: Z-2148-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2148-2023
    Event ID
    92558
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bryan Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 26, 2023
    Initiation Date
    May 16, 2023
    Classification Date
    July 17, 2023
    Address
    6100 Wooster Pike, N/A, Cincinnati, OH, 45227-4209, United States

    Description

    Aeris Balloon Dilation Catheter

    Reason

    Devices were mislabeled.

    Code Info

    Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.

    Distribution

    US Nationwide distribution in the states of GA, NY, & PA.

    Quantity

    5 units