BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1602-2023 · Initiated March 28, 2023

    Recall

    Recall Number
    Z-1602-2023
    Event Number
    92114
    Firm
    Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom
    FEI Number
    3002808173
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    March 28, 2023
    Posted
    May 17, 2023

    Description

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

    Reason

    Optical Trocars sterility assurance can not be guaranteed

    Action

    On March 29, 2023, Surgical Innovations issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. An update to the communication was sent on 4/17/2023 to affected consignees via E-Mail. In addition to informing consignees about the recall, Surgical Innovations ask consignees to take the following action: 1. Distributor should confirm receipt of this Field Safety Notice 2. Identify the devices held in stock at the distributor and quarantine affected batches awaiting further instruction. 3. Issue this Field Safety Notice to all end users (Hospital) that the distributor has supplied 4. All product still in stock at the end users must be returned to the distributor. 5. Confirmation must be obtained by the distributor that either all stock has been returned or that any other product has been successfully used. 6. Confirmation to Surgical Innovations using the attached form of this disposition of all stock 7. Await further instruction from Surgical Innovations regarding further action for the affected products.

    Distribution

    US: MA OUS: None

    Quantity

    3405 units