NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has issued a vital correction for its NOxBOXi Nitric Oxide Delivery System. This update addresses significant safety concerns related to dosing fluctuations of nitric oxide when used with certain ventilators. Health care professionals, clinical educators, and regulatory teams should prioritize addressing this development to mitigate risks for patient care.
What is the affected product?
The NOxBOXi Nitric Oxide Delivery System is designed to administer and monitor precise concentrations of nitric oxide to patients undergoing inhaled nitric oxide therapy. The system also tracks nitrogen dioxide and oxygen levels in inspiratory ventilator lines. All models and serial numbers of the NOxBOXi system are impacted by this update.
Why was the update issued?
Reports from clinicians using the NOxBOXi system highlighted severe dosing fluctuations surpassing ±20% of the prescribed nitric oxide dose. These irregularities primarily occurred when the system was used alongside the Bunnell LifePulse High Frequency Jet Ventilator or certain conventional ventilators under specific conditions. Such fluctuations could result in therapy interruptions—potentially causing blood oxygen desaturation, elevated pulmonary artery pressure, or even death.
As of August 28, 2025, NOxBOX Ltd. confirmed three serious injuries tied to this issue. No fatalities have been reported.
What steps should clinicians take?
Immediate troubleshooting measures:
- Ensure all personnel understand and implement troubleshooting recommendations detailed within the manufacturer’s urgent correction letter.
- Verify that the NOxBOXi device has been placed into High Frequency Jet Ventilator (HFJV) mode during use.
- Check that the device has undergone recent calibration (within the last 30 days) and system tests (within the last seven days).
- Confirm stability of ventilator settings before administering nitric oxide therapy.
Preventive measures:
- Utilize the alternative one-way valve patient kit recommended by NOxBOX Ltd.
- Secure all tubing, filters, and connections to avoid occlusions, blockages, or moisture buildup.
- Inspect the NOxFLOW sensor and related connections for proper placement and orientation.
- Replace deteriorated NOxFLOW sensors promptly.
How is NOxBOX Ltd. responding?
NOxBOX Ltd. is actively developing a new software update to resolve the dosing fluctuation issue. Upon release, the manufacturer will coordinate with affected customers to implement the software update. Until then, clinicians are urged to adhere fully to the recommended actions outlined in the correction letter.
How can adverse events be reported?
Health care professionals and consumers can report adverse reactions or quality issues arising from the use of the NOxBOXi system through the FDA’s MedWatch program. Accurate reporting will aid in addressing the matter promptly.
Who should you contact?
Clinicians in the U.S. can reach the NOxBOX Customer Excellence Center at 1-833-NOX-VENT (669-8368) or email inquiries to LG.US.NOXIVENT@Linde.com.
Conclusion
This recall highlights a severe safety concern requiring urgent action by affected health care providers. The NOxBOXi Nitric Oxide Delivery System presents risks of dosing irregularities that may result in patient harm if not addressed. All personnel involved in nitric oxide therapy should review and apply the recommended measures from NOxBOX Ltd. promptly to safeguard patient outcomes.
Disclaimer
This blog is intended for informational purposes only and does not constitute legal or clinical advice. Health care professionals should consult with regulatory experts or official FDA resources for compliance-related guidance.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-noxbox-ltd-issues-correction-noxboxi-nitric-oxide-delivery-system-due-risk-nitric-oxide-dosing