BEUDAMED
    FDA Enforcement Class II Ongoing

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

    Recall: Z-0938-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0938-2025
    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 YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

    Reason

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

    Code Info

    1) 96-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5; 2) 96-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5; 3) 96-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5; 4) 96-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6; 5) 96-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5; 6) 96-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5; 7) 96-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5; 8) 96-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5; 9) 96-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5; 10) 96-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5; 11) 96-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5; 12) 96-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5.

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    150 units