BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    Recall: Z-0777-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0777-2024
    Event ID
    93580
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 31, 2024
    Initiation Date
    June 9, 2023
    Classification Date
    January 20, 2024
    Address
    Akcaburgaz Mahallesi, Muhsin Yazicioglu Caddesi No:45/5, Esenyurt, N/A, N/A, Turkey

    Description

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    Reason

    Sterility of Ultrasound gel can not be guaranteed.

    Code Info

    Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019

    Distribution

    US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong

    Quantity

    4,923,471