Recall Z-2198-2025— Capnia Inc
Class II · Ongoing
Class II FDA medical device recall by Capnia Inc, initiated 2025-04-21. It names one FDA 510(k) clearance: K151107. Product: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor. 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..
- Recalling firm
- Capnia Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-21
- Firm location
- Foster City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.