BEUDAMED
    FDA Enforcement Class II Ongoing

    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

    Recall: Z-0718-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0718-2024
    Event ID
    93629
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2024
    Initiation Date
    December 4, 2023
    Classification Date
    January 12, 2024
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    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).

    Code Info

    UDI-DI 00821925043985 Lot KR262848

    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