Z-2198-2025 Class II Ongoing
FDA device recall Z-2198-2025 was initiated by Capnia Inc on April 21, 2025 and is designated Class II. 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 car… The recall status is ongoing. Affected quantity: 2160.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- April 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2160
Product Description
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 Pattern
US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
Code Information
Monitor UDI-DI: 00858481006017. Lot (C20206): 231220