BEUDAMED
    FDA Enforcement Class II Ongoing

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    Recall: Z-0930-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0930-2025
    Event ID
    95946
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sklar Instruments
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 3, 2024
    Classification Date
    January 16, 2025
    Address
    1333 Lenape Rd, West Chester, PA, 19382-6816, United States

    Description

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    Reason

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Code Info

    1) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    175 units