BEUDAMED
    FDA Enforcement Class II Ongoing

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy

    Recall: Z-0943-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0943-2025
    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 SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy

    Reason

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

    Code Info

    1) 96-4113, UDI/DI 50649111492899, Lot codes: SK-133; 2) 96-4144A, UDI/DI 50649111492523, Lot codes: HSC21; 3) 96-4145A, UDI/DI 50649111492608, Lot codes: HSC21.

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    0 units