BEUDAMED
    FDA Enforcement Class II Completed

    YelloPort Elite Universal Seal. For use in laparoscopic procedures.

    Recall: Z-1396-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1396-2022
    Event ID
    90447
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Surgical Innovations Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    June 2, 2022
    Classification Date
    July 18, 2022
    Address
    Clayton House, 6 Clayton Wood Rise, Leeds, N/A, N/A, United Kingdom

    Description

    YelloPort Elite Universal Seal. For use in laparoscopic procedures.

    Reason

    There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

    Code Info

    All Lots; UDI/DI:05051986001562

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, IN, WA, MA and the countries of Armenia, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Ecuador, UK, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, N. Ireland, Norway, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Dubai.

    Quantity

    N/A