Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
This recall is currently active, issued July 29, 2025. It was issued by Capnia Inc.
- Company
- Capnia Inc
- Recall Initiated
- April 21, 2025
- Posted
- July 29, 2025
- Recall Number
- Z-2198-2025
- Quantity
- 2160
- Firm Location
- Foster City, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Root Cause
Device Design
Action Taken
Starting on 4/21/2025 Product Advisory and Voluntary Field Action emails were sent to customers who were told affected devices would be replaced. Customers with questions could contact the firm at 904-588-2986