Tag: neonates

FDA Issues Early Alert for NOxBOX Nitric Oxide Delivery Systems Over Oxygen Leak Risks

24 Aug 2026 12:51 p.m. · Source: US Food and Drug Administration

The FDA issued an "Early Alert" for NOxBOX nitric oxide delivery systems due to oxygen leaks. These leaks could cause increased nitric oxide dosage or therapy interruption, posing risks like methemoglobinemia and oxygen desaturation, especially for neonates.

Health Politics and Government Business Medical Science Federal Government Social Issues FDA NOxBOX Nitric Oxide Delivery System Medical Device Oxygen Leaks Methemoglobinemia Neonates Food Recalls Drugs