BEUDAMED
    FDA Enforcement Class II Terminated

    Aspiration Syringe Kit, REF: MVSK60

    Recall: Z-0202-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0202-2022
    Event ID
    88892
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MICROVENTION INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    October 20, 2021
    Classification Date
    November 4, 2021
    Termination Date
    May 15, 2024
    Address
    35 Enterprise, N/A, Aliso Viejo, CA, 92656, United States

    Description

    Aspiration Syringe Kit, REF: MVSK60

    Reason

    Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

    Code Info

    Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461

    Distribution

    US Nationwide distribution in the states of AL, NY, NV.

    Quantity

    33