NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
⚠️ Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Is this relevant to me?
- Geography
- TN
- Source agency
- FDA
- Category
- Health
- Published
- September 9, 2025
Domestic: TN
What's affected?
- Product
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Brand
- NOXBOX LTD
- Lot code
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Additional details
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 1667 units.
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