BEUDAMED
    FDA Enforcement Class II Terminated

    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

    Recall: Z-1570-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1570-2023
    Event ID
    92005
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    New Wave Endo-Surgical, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 17, 2023
    Initiation Date
    July 8, 2020
    Classification Date
    May 9, 2023
    Termination Date
    July 2, 2024
    Address
    6601 Lyons Rd Ste D8, N/A, Coconut Creek, FL, 33073-3630, United States

    Description

    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

    Reason

    The plastic housing on the device may fracture

    Code Info

    UDI/DI: 00850009417022, Lot code C2020

    Distribution

    US Nationwide distribution in the states of FL, MA, and GA.

    Quantity

    295 units