BEUDAMED
    FDA Recall Open, Classified

    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

    Recall: Z-0718-2024 · Initiated December 4, 2023

    Recall

    Recall Number
    Z-0718-2024
    Event Number
    93629
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 4, 2023
    Posted
    January 12, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

    Reason

    Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).

    Action

    On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at [email protected].

    Distribution

    Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.

    Quantity

    179 units