BEUDAMED
    FDA Enforcement Class II 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 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0557-2021
    Event ID
    86873
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mani, Inc. - Kiyohara Facility
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2020
    Initiation Date
    October 27, 2020
    Classification Date
    December 10, 2020
    Termination Date
    August 11, 2021
    Address
    Park 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi, Utsunomiya, N/A, N/A, Japan

    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

    Code Info

    Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03

    Distribution

    US Nationwide distribution in the state of MO.

    Quantity

    6 units (US)