NOxBOXi Nitric Oxide Delivery System Corrected Due to Oxygen Leaks
The US FDA has issued a device recall notice regarding the NOxBOXi Nitric Oxide Delivery System with the NOxMixer module due to reports of oxygen leaks. These leaks stem from issues with the internal oxygen tubing or tubing connection within the NOxMixer module, which can cause therapy interruption or increased nitric oxide dosage. Affected units do not need to be removed from service immediately unless they fail pre-use checks, as the manufacturer is providing updated instructions and arranging hardware repairs.
To mitigate risks, the manufacturer advises users to complete all pre-use system checks, ensure secure oxygen supply connections, check the flowmeter, and keep at least one back-up device available. Neonates with congenital heart disease are highlighted as facing greater risks from potential treatment complications.
Key points
- Affected products include the NOxBOXi Nitric Oxide Delivery System with the NOxMixer module.
- Oxygen leaks can result from failures in the internal oxygen tubing or tubing connections.
- Complications can include therapy interruption, oxygen desaturation, increased pulmonary artery pressure, and methemoglobinemia.
- Users must verify device function using updated pre-use inspection instructions and ensure backup devices are accessible.
What it means for you
Clinicians and hospital staff utilizing nitric oxide delivery systems should review the updated pre-use inspection instructions and ensure that backup equipment is readily available in case of device failure. Healthcare providers in Pakistan should check with local suppliers and the Drug Regulatory Authority of Pakistan (DRAP) for information regarding the local availability of these devices and specific manufacturer advisories.
Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.