|
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., is correcting NOxBOXi Nitric Oxide Delivery System due to safety considerations associated with using this nitric oxide delivery system together with the Bunnell LifePulse High Frequency Jet Ventilator and potentially other conventional ventilators. Customers reported fluctuations in the monitored nitric oxide value (greater than ±20% of the set dose) when the NOxBOXi system is used with specific settings on the Bunnel LifePulse. This issue may cause an interruption to therapy, leading to a drop in blood oxygen levels (desaturation) or increased pressure in the artery that carries oxygen from the heart to the lungs (pulmonary artery).
The use of affected product may cause serious adverse health consequences, including a drop in blood oxygen levels (desaturation), increased artery pressure, and death.
As of August 28, 2025, NOxBOX Ltd. has reported three serious injuries and no deaths associated with this issue.
This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact their local clinical educator or the NOxBOX Customer Excellence Center at 1-833-NOX-VENT (669-8368) or LG.US.NOXIVENT@Linde.com.
|
