Capnia Inc: Device Recall
Recall #Z-2198-2025 · 04/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2198-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Capnia Inc
- Status
- Ongoing
- Date Initiated
- 04/21/2025
- Location
- Foster City, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2160
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.
Product Description
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Distribution Pattern
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.