BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1570-2023 · Initiated July 8, 2020

    Recall

    Recall Number
    Z-1570-2023
    Event Number
    92005
    Firm
    New Wave Endo-Surgical, Corp.
    FEI Number
    3015209038
    Product Code
    HCF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 8, 2020
    Posted
    May 9, 2023
    Terminated
    July 2, 2024
    Address
    6601 Lyons Rd, Ste D8, Coconut Creek, FL, 33073-3630

    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

    Action

    New Wave Endo issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION to its consignees by email on 07/08/2020. The notice explained the problem with the device and requested the consignee quarantine the device and respond using the recall acknowledgement form. The units were returned and replaced.

    Distribution

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

    Quantity

    295 units