NOxBOXi Nitric Oxide Delivery System may cause dose fluctuations under specific conditions
NOxBOXi Nitric Oxide Delivery Systems may experience dose fluctuations when operating at certain parameters, potentially affecting treatment reliability. The FDA issued a Class I recall affecting 1,667 units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls have a regulatory minimum severity of 4 per the rubric. No injuries, illnesses, or deaths are reported in the source text.
Plain-English summary
The NOxBOXi Nitric Oxide Delivery System, Model NOXBOX-I, manufactured by NOXBOX LTD, is the subject of an FDA Class I recall.
The device may experience fluctuations in nitric oxide dose delivery under specific operating conditions. These include scenarios where the total flow through the device sensor is less than the minimum requirement of 0.5 liters per minute, when service pressures fall below 3.0 PSI, when the pressure difference exceeds 5.0 cm H2O, or at breath rates of 300 breaths per minute. Dose fluctuations may occur when the NOxBOXi is used with Bunnel LifePulse HFJV systems or conventional ventilators operating under these parameters.
A total of 1,667 units were distributed domestically in Tennessee.
Healthcare facilities should review the operating conditions and parameters of their NOxBOXi systems and contact NOXBOX LTD for guidance on managing or replacing affected units.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Manufacturer
- NOXBOX LTD
- Category
- Medical Device — Respiratory
- Hazard
- dose-fluctuation
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer))
- (2) REQNOXBOXI (Linde (U.S. Distributor))
- UDI-DI: 05060541640009
- All serial numbers.
Distribution
Distributed in 1 state:
- TN
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