Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
FDA device recall Z-2198-2025 · posted 2025-07-29 · Open, Classified
Recall details
- Recalling firm
- Capnia Inc
- 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.
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- CCJ
- Quantity affected
- 2160
- Distribution
- US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
- Date initiated
- 2025-04-21
- Date posted
- 2025-07-29
- Location
- Foster City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CoSense ETCO Monitor (K151107) | Capnia, Inc. | 2015-07-22 |