FDAHealthApril 21, 2025
Capnia Inc — Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2025
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
What's affected?
- Product
- Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- Brand
- Capnia Inc
- Lot code
- (C20206):
Additional details
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2160.
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