BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

    Recall: Z-1431-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1431-2023
    Event ID
    91984
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    March 22, 2023
    Classification Date
    April 25, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

    Reason

    The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

    Code Info

    1. Lot #95475, exp. 10/29/2024, UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493, exp. 9/7/2024, UDI (01)10194717112327(17)240907(10)95493.

    Distribution

    US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

    Quantity

    278 kits