BEUDAMED
    FDA Recall Terminated

    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    Recall: Z-1667-2023 · Initiated May 3, 2023

    Recall

    Recall Number
    Z-1667-2023
    Event Number
    92171
    FEI Number
    3012796317
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 3, 2023
    Posted
    June 9, 2023
    Terminated
    October 31, 2024
    Address
    NOXBOX LTD Unit 1080 & 1081 Galley Drive; Kent Science Park Sittingbourne United Kingdom

    Description

    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    Reason

    Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

    Action

    On May 3, 2023, the firm notified customers via URGENT MEDICAL DEVICE RECALL letters. Devices do not need to be removed from service unless they do not pass the start-up high-pressure leak test or it alarms during cylinder changeover and troubleshooting does not resolve the alarms. Customers should prioritize use of a device that is not affected, if available, when initiating therapy on a new patient. If there are no unaffected devices available, or if an affected device is already in use on a patient, follow troubleshooting measures as provided in the letter. Once new manifolds are available, NBL will correct or replace affected devices on a rolling basis. If you have any questions or require further assistance, please contact your sales representative or customer service at 833-NOX-VENT.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom.

    Quantity

    548 (US); 208 (OUS)