Class II

Medical Device Recall: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Capnia Inc · April 21, 2025

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.

Distribution

US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.

States Affected

NATIONWIDE

Quantity Affected

2160

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2198-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Capnia Inc Medical Device Recall: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor | SafeCheck