BEUDAMED
    FDA Recall Open, Classified

    UroPass Ureteral Access Sheaths, 5 pieces/box

    Recall: Z-2401-2023 · Initiated May 19, 2023

    Recall

    Recall Number
    Z-2401-2023
    Event Number
    92495
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    KNY
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2023
    Posted
    August 14, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    UroPass Ureteral Access Sheaths, 5 pieces/box

    Reason

    Dilator tips may break in the package and in patients during surgical procedures.

    Action

    A customer notification letter was issued to customers on May 19, 2023. Customers were requested to identify affected product; cease and quarantine any product manufactured prior to December 31, 2019. Acknowledgement of receipt should be made to Olympus per the instructions in the recall letter.

    Distribution

    Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.

    Quantity

    9520 eaches