HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
NOXBOX Recalls Nitric Oxide Delivery System Over Dose Fluctuations
NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on September 9, 2025. The recall stems from dangerous dose fluctuations that could occur under specific device settings. Healthcare providers and patients should stop using the device immediately.
Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- NOXBOX
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
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).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: E-Mail
Product Details
The recalled product is the NOxBOXi Nitric Oxide Delivery System, model number NOXBOX-I. It was distributed domestically in Tennessee.
The Hazard
Fluctuations may occur if the flow through the device sensor is less than 0.5 LPM. Dose fluctuations have been observed with specific settings on Bunnel LifePulse HFJV systems or conventional ventilators.
Reported Incidents
The recall is classified as Class I, indicating a high hazard level. There are no specific reports of injuries or incidents mentioned.
What to Do
Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact NOXBOX LTD or your healthcare provider for further guidance.
Contact Information
For questions, reach NOXBOX LTD via email or consult your healthcare provider. Further details are available on the FDA's website.
Key Facts
- Recall date: September 9, 2025
- Quantity recalled: 1,667 units
- Hazard classification: Class I
- Location: Tennessee
- Manufacturer: NOXBOX
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeNitric Oxide Delivery System
Sold At
Unknown
Product Details
Brand
Categories
Model Numbers
NOXBOX-I
NBL
REQNOXBOXI
UDI-DI: 05060541640009
Affected States
TN
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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