Recall Z-2198-2025
Capnia Inc · initiated April 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Codes / lots: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Reason for recall
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
FDA-determined cause: Device Design
Action taken
Starting on 4/21/2025 Product Advisory and Voluntary Field Action emails were sent to customers who were told affected devices would be replaced. Customers with questions could contact the firm at 904-588-2986
Details
- Recall number
- Z-2198-2025
- Initiated
- April 21, 2025
- Posted by FDA
- July 29, 2025
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Quantity
- 2160
- Distribution
- US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
- Recalling firm
- Capnia Inc, Foster City, CA