BEUDAMED
    FDA Enforcement Class II Terminated

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    Recall: Z-1468-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1468-2023
    Event ID
    91829
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mani, Inc. - Kiyohara Facility
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 3, 2023
    Initiation Date
    February 20, 2023
    Classification Date
    April 26, 2023
    Termination Date
    May 19, 2025
    Address
    Park 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi, Utsunomiya, N/A, N/A, Japan

    Description

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    Reason

    A packaging defect may compromise the sterile barrier.

    Code Info

    UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)

    Distribution

    Distribution in US - 1 consignee in Missouri

    Quantity

    45 kits