Z-0028-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1667 units
Product Description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Reason for Recall
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).
Distribution Pattern
Domestic: TN
Code Information
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.