BEUDAMED
    FDA Recall Terminated

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    Recall: Z-0557-2021 · Initiated October 27, 2020

    Recall

    Recall Number
    Z-0557-2021
    Event Number
    86873
    Firm
    Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan
    FEI Number
    3002692886
    Product Code
    NGY
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 27, 2020
    Terminated
    August 11, 2021

    Description

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    Reason

    Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

    Action

    MANI Inc. issued Voluntary Removal letter issued on 10/27/20 via email to the US Distributor stating reason for removal, health risk and action to take: request distributors to return the devices. If there are MANI TROCAR KIT and MANI INFUSION CANNULA in your stock and/or your customer's stock: Please write the returning Q'ty. in the list ,"Returned" If MANI TROCAR KIT and MANI INFUSION CANNULA are already used up : Please write the used Q'ty. in the list , "Used. Please send this sheet and relevant items if you have to our address below. Any costs/fees related to this return shipment should be charged to MANI FedEx account. MANI, INC. 8-3, Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231, Japan

    Distribution

    US Nationwide distribution in the state of MO.

    Quantity

    6 units (US)