BEUDAMED
    FDA Enforcement Class II Terminated

    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

    Recall: Z-1250-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1250-2022
    Event ID
    90135
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2022
    Initiation Date
    May 3, 2022
    Classification Date
    June 8, 2022
    Termination Date
    May 31, 2024
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

    Reason

    Potential for the tip of the electrode to detach during use.

    Code Info

    Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024)

    Distribution

    Distributed to North Carolina.

    Quantity

    125 units