BEUDAMED
    FDA Enforcement Class II Ongoing

    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

    Recall: Z-1852-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1852-2022
    Event ID
    90801
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Surgical Innovations Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    January 20, 2022
    Classification Date
    September 29, 2022
    Address
    6 Clayton Wood Bank, Lds, Leeds, N/A, N/A, United Kingdom

    Description

    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

    Reason

    Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

    Code Info

    Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029

    Distribution

    US: MA

    Quantity

    19