BEUDAMED
    FDA Recall Completed

    YelloPort Elite Universal Seal. For use in laparoscopic procedures.

    Recall: Z-1396-2022 · Initiated June 2, 2022

    Recall

    Recall Number
    Z-1396-2022
    Event Number
    90447
    Firm
    Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom
    FEI Number
    3002808173
    Product Code
    GCJ
    Status
    Completed
    Root Cause
    Process change control
    Initiated
    June 2, 2022

    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.

    Action

    On June 2, 2022, Surgical Innovation issued a "urgent Field Safety Notice. On 6/8/2022, Surgical Innovations issued an "updated: Urgent Medical Device Recall notification via E-Mail to provide additional information and a revised recall strategy. The updated communication, ask consignees to take the following actions: 1.Identify the devices and quarantine all stock. 2. All product still in stock at end users must be returned to the distributor. 3. Confirmation that all such stock has been returned and that any other product has been successfully used must be obtained by the distributor. 4. The distributor shall inform Surgical Innovations of the quantities and an RMA will be provided by Surgical Innovations for return off the product to Surgical Innovations. 5. The devices shall then be returned to Surgical Innovations of disposition and the Distributor compensated for the carriage fees. 6. Replacement devices, as appropriate, which do not have this issue, will be provided by Surgical Innovations.

    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.