NOxBOXi Nitric Oxide Delivery System Recall for Newborns and Newborns | Image credit: © Balint Radu – © Balint Radu – Stock.adobe.com.
NOxBOX Ltd has recalled the NOxBOXi Nitric Oxide Delivery System (NOxBOXi) because maladjusted check valves can cause leaks of oxygen or nitric oxide, causing interruptions in nitric oxide therapy, the FDA said. said in a press release. The FDA has classified this recall as a Class I, the most serious type of recall. The press release stated that affected devices could cause serious injury or death to neonatal and neonatal patient populations.
NOxBOXi delivers a constant concentration of nitric oxide (NO) medical gas for oxide therapy through a ventilator that supports the patient’s breathing. This product is approved for use in neonates, including those with congenital heart disease.
Misaligned check valves on the manifold can cause manifold failure. If this fails, nitric oxide or oxygen may leak. According to the press release, NOxBOXi may “replace gas cylinders sooner than expected, or not at all.” These problems can interrupt nitric oxide therapy, resulting in low blood oxygen levels and increased pressure in the pulmonary arteries that carry oxygen from the heart to the lungs. This potential disruption can pose a significant risk to newborns with congenital heart disease. As of 13th July 2023, NOxBOX Ltd has reported no deaths or injuries due to this issue and 767 devices have been recalled as of this date.
On May 2, 2023, NOxBOX Ltd sent an emergency medical device recall letter with some recommendations to affected customers. For more information on recommended actions for affected customers and healthcare professionals, please visit click here. NOxBOX Ltd will progressively modify or replace affected devices as new manifolds become available.
reference:
NOxBOX Ltd. is recalling the NOxBOXi nitric oxide system due to a manifold failure that could cause gas leaks and interrupt treatment to neonates. press release. FDA. July 13, 2023. Accessed 14 July 2023. https://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxyde-system-manifold-failure-may-cause-gas-leaks-and-interrupt? utm_medium=email&utm_source=govdelivery
This article was originally published by our sister journal, Contemporary Pediatrics®.
