BEUDAMED
    FDA Enforcement Class II Ongoing

    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

    Recall: Z-1602-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1602-2023
    Event ID
    92114
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Surgical Innovations Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2023
    Initiation Date
    March 28, 2023
    Classification Date
    May 17, 2023
    Address
    6 Clayton Wood Bank, Lds, Leeds, N/A, N/A, United Kingdom

    Description

    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

    Reason

    Optical Trocars sterility assurance can not be guaranteed

    Code Info

    Lot # 738182 ; UDI-DI: (01) 05051986013428

    Distribution

    US: MA OUS: None

    Quantity

    3405 units