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Open, Classified

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

FDA Recall Z-2198-2025 · Posted 2025-07-29

Recalling FirmCapnia Inc
Recall StatusOpen, Classified
Product CodeCCJ
Date Initiated2025-04-21
Product Quantity2160

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.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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