NOxBox Ltd. has recalled 1,667 units of the NOxBOXi Nitric Oxide Delivery System because the device may experience dose fluctuations during treatment. This issue is more likely to occur when the gas flow is below 0.5 liters per minute or when specific ventilator settings are used, such as very high breath rates or low service pressures. These devices are used in clinical settings to deliver precise amounts of nitric oxide gas to patients.
Inconsistent delivery of nitric oxide gas can result in patients receiving too much or too little medication, which may lead to inadequate oxygen levels in the blood or other serious respiratory complications.
Fluctuations observed when total flow is less than 0.5 LPM, or with ventilator settings including low service pressures (< 3.0 PSI), pressure differences > 5.0cm H2O, or breath rates of 300 BPM (5 Hz).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.