Recall Z-2198-2025 ยท CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Capnia Inc
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
| Date | Jul 29, 2025 (initiated Apr 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 2160 |
| Distribution | US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151107 | CoSense ETCO Monitor Capnia, Inc., Jul 22, 2015 |