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

Hazard

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.

Details from the source

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. Quantity: 2160 Lot/code info: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220

UPC codes

00858481006017

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.