BEUDAMED
    FDA Recall Open, Classified

    Duravent Silicone Ventilation Tube. Model Number: 240075.

    Recall: Z-0707-2025 · Initiated November 19, 2024

    Recall

    Recall Number
    Z-0707-2025
    Event Number
    95716
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    ETD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 19, 2024
    Posted
    December 19, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Duravent Silicone Ventilation Tube. Model Number: 240075.

    Reason

    Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

    Action

    Olympus notified consignees on 11/19/2024 via Courier, 2-day delivery. Consignees were instructed to examine inventory for affected devices, quarantine any affected devices on hand, arrange for return of those affected units and acknowledge receipt of the customer letter through the web portal.

    Distribution

    AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

    Quantity

    984 units