Capnia Inc recalls Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Recall date

April 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2198-2025

FDA classification

Class II

Brand / firm

Capnia Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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