BEUDAMED
    FDA Enforcement Class II Ongoing

    ASG-001; Ultrasound gel

    Recall: Z-2532-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2532-2023
    Event ID
    92735
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advance Medical Designs, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 20, 2023
    Initiation Date
    July 7, 2023
    Classification Date
    September 8, 2023
    Address
    1241 Atlanta Industrial Dr, Marietta, GA, 30066-6606, United States

    Description

    ASG-001; Ultrasound gel

    Reason

    Ultrasound gel mislabeled with inappropriate use.

    Code Info

    Not individually distributed

    Distribution

    US, Canada, UK, Panama, Netherlands