BEUDAMED
    FDA Recall Open, Classified

    procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-GG023, b) 28-GG105, c) 28-GG107, d) 28-GG121, e) 28-GG219, f) 28-GG223, g) 28-GG303, h) 28-GG307, i) 28-GG519, j) 28-GG519PC, k) 28-GG521, l) 28-GG521PC, m) 28-GG529, n) 28-GG553, o) 28-GG569, p) 28-GG571, q) 28-GG723

    Recall: Z-2537-2023 · Initiated July 7, 2023

    Recall

    Recall Number
    Z-2537-2023
    Event Number
    92735
    Firm
    Advance Medical Designs, Inc.
    FEI Number
    1037885
    Product Code
    GDF
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    July 7, 2023
    Posted
    September 9, 2023
    Address
    1241 Atlanta Industrial Dr, Marietta, GA, 30066-6606

    Description

    procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-GG023, b) 28-GG105, c) 28-GG107, d) 28-GG121, e) 28-GG219, f) 28-GG223, g) 28-GG303, h) 28-GG307, i) 28-GG519, j) 28-GG519PC, k) 28-GG521, l) 28-GG521PC, m) 28-GG529, n) 28-GG553, o) 28-GG569, p) 28-GG571, q) 28-GG723

    Reason

    Ultrasound gel mislabeled with inappropriate use.

    Action

    Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.

    Distribution

    US, Canada, UK, Panama, Netherlands

    Quantity

    1880 units