FDA-Device2025-08-06Class II
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Capnia Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Affected count
2160
Manufactured in
1101 Chess Dr, Foster City, CA, United States
Products
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2025Don't want to check this manually?
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