BEUDAMED
    FDA Enforcement Class II Terminated

    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

    Recall: Z-1878-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1878-2018
    Event ID
    79911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro-Tech (Nanjing) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 23, 2018
    Initiation Date
    March 12, 2018
    Classification Date
    May 15, 2018
    Termination Date
    August 30, 2018
    Address
    High Tech, NO. 10 Gaoke Third Road Nanjing National, Nanjing, N/A, China

    Description

    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

    Reason

    The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.

    Code Info

    Identifier EUS-22-0-N UPN ES34601 M171226172

    Distribution

    US distribution to one distributor in MI.

    Quantity

    40 total