CoSense sampling sets may carry residual carbon monoxide from insufficient aeration
Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: the manufacturer states the sets may produce higher than expected readings during clinical evaluation, with no patient harm reported.
Plain-English summary
The Precision Sampling Set, REF C20206, for use with the CoSense End-Tidal Carbon Monoxide Monitor, is being recalled. The action covers 2,160 units from lot 231220, with monitor UDI-DI 00858481006017.
According to the manufacturer, the sampling set nasal cannula 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 ETCOc scores during clinical evaluations. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was nationwide in the United States, in Pennsylvania, Utah, Texas, Florida, Massachusetts and Iowa.
Facilities should identify affected stock using the REF and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- Manufacturer
- Capnia Inc
- Category
- Medical Device — Sampling set
- Hazard
- residual-carbon-monoxide
- erroneous-results
- insufficient-aeration
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Distribution
Distributed nationwide across the United States.
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