NOxBOXi Nitric Oxide Delivery System recalled for newborns, neonates
The FDA has identified NOxBOX Ltd’s recall of NOxBOXi Nitric Oxide Delivery System as a Class I recall. Affected devices to the newborn and neonate patient populations can cause nitric oxide therapy interruptions because of a check valve misalignment. As of July 13, 2023, no injuries or deaths have been reported according to the federal agency.
NOxBOXi Nitric Oxide Delivery System recalled for newborns, neonates | Image Credit: © Balint Radu - © Balint Radu - stock.adobe.com.
NOxBOX Ltd has recalled NOxBOXi Nitric Oxide Delivery Systems (NOxBOXi) because of a check valve misalignment that could lead to oxygen or nitric oxide leaks, potentially causing nitric oxide therapy interruptions, the FDA stated in a press release. The FDA has identified the recall as a Class I, the most serious type of recall. The press release states affected devices could result in serious injury or death for the patient population of newborns and neonates.
Through a ventilator that provides breathing support to the patient, NOxBOXi delivers a constant concentration of nitric oxide (NO) medical gas for oxide therapy. The product is approved for newborn or neonate use, including those with congenital heart disease.
A misalignment of the check valve located in the manifold could cause the manifold to fail. Nitric oxide or oxygen could leak if this fails. NOxBOXi could “change gas cylinders earlier than expected or not at all,” according to the press release. These issues could cause an interruption to nitric oxide therapy, resulting in a drop in blood oxygen levels, or increased pressure in the pulmonary artery, which carries oxygen from the heart to the lungs. This potential interruption could pose greater risks to neonates with congenital heart disease. As of July 13, 2023, NOxBOX Ltd has reported no deaths or injuries to this issue, and 767 devices have been recalled as of this date.
On May 2, 2023, NOxBOX Ltd sent an Urgent Medical Device Recall letter to affected customers with several recommendations. For more information regarding recommended actions for affected customers and health care professionals, click here. Once new manifolds are available, NOxBOX Ltd will correct or replace affected devices on a rolling basis.
Reference:
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonates. Press release. FDA. July 13, 2023. Accessed July 14, 2023. https://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt?utm_medium=email&utm_source=govdelivery
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