BEUDAMED
    FDA Enforcement Class II Ongoing

    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

    Recall: Z-1435-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1435-2023
    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 kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

    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

    Lot #95517, exp. 10/17/2024, UDI (01)10194717108719(17)241017(10)95517.

    Distribution

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

    Quantity

    386 kits