FDA recall Z-2198-2025

Capnia Inc · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-04-21
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Foster City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2025