BEUDAMED
    FDA Enforcement Class II Ongoing

    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning

    Recall: Z-0925-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0925-2025
    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 brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning

    Reason

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

    Code Info

    1) 96-2273, UDI/DI 50649111448735, Lot Codes: SK-129; 2) 96-2283, UDI/DI 50649111448780, Lot Codes: SK-129

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    25 units