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Recall Observatory FDA recall evidence

Device product

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

Z-2198-2025

April 21, 2025

Class II

Product summary

Firm
Capnia Inc
Event
Event 97184
Status
Ongoing
Classification
Class II
Quantity
2160
Official record key
device-enforcement:Z-2198-2025

Official wording

Reason: 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.

Code information: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.