BEUDAMED
    FDA Enforcement Class I Terminated

    regard Operative LAP, Item Number 800943001; surgical convenience kit

    Recall: Z-0620-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0620-2024
    Event ID
    93653
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 24, 2024
    Initiation Date
    December 18, 2023
    Classification Date
    January 12, 2024
    Termination Date
    October 3, 2024
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    regard Operative LAP, Item Number 800943001; surgical convenience kit

    Reason

    Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

    Code Info

    UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

    Distribution

    US distribution to Louisiana

    Quantity

    345 units