Nitric oxide delivery systems recalled over dose fluctuations at low flow
NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because delivered dose may fluctuate when total flow through the device sensor falls below its 0.5 LPM minimum.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The NOxBOXi Nitric Oxide Delivery System, model NOXBOX-I, is being recalled over dose fluctuations.
Fluctuations may be more likely to occur if the total flow through the device sensor, which the device uses to determine flow, is less than the minimum device requirement of 0.5 LPM. Dose fluctuations have also been observed when a Bunnell LifePulse HFJV system or conventional ventilators are set to low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0 cm H2O, or breath-per-minute rates of 300 (5 Hz).
The recall covers 1,667 units, distributed in Tennessee. The device carries model numbers NOXBOXI from the manufacturer and REQNOXBOXI from the US distributor. The FDA has classified the recall as Class I.
Clinicians using the system should follow the manufacturer's instructions and pay particular attention to the flow and ventilator settings identified in the notice.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Manufacturer
- NOXBOX LTD
- Affected units
- 1,667
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:
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