BEUDAMED
    FDA Enforcement Class II Ongoing

    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.

    Recall: Z-0314-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0314-2025
    Event ID
    95480
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2024
    Initiation Date
    April 29, 2022
    Classification Date
    November 6, 2024
    Address
    15353 Barranca Pkwy, N/A, Irvine, CA, 92618-2216, United States

    Description

    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.

    Reason

    Due to products being shipped/distributed to customers after the products expiration date had past.

    Code Info

    Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB

    Distribution

    U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.

    Quantity

    17 devices