Precision Sampling Sets may contain residual carbon monoxide affecting measurements
Precision Sampling Sets used with CoSense End-Tidal CO Monitors may contain residual carbon monoxide and volatile organic compounds due to insufficient aeration during manufacturing. This may cause inaccurate readings during clinical evaluations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with a manufacturing defect (insufficient aeration of the carbon filter). No illnesses or injuries have been reported, and the hazard is theoretical—the devices may produce inaccurate measurements rather than direct patient harm.
Plain-English summary
Capnia Inc is recalling Precision Sampling Sets (reference C20206) used with the CoSense End-Tidal Carbon Monoxide Monitor. These nasal cannulas are used in clinical settings to measure carbon monoxide exposure.
The sampling sets may contain residual carbon monoxide and volatile organic compounds in the carbon filter due to insufficient aeration prior to sealing during manufacturing. This defect may cause the devices to produce higher than expected end-tidal carbon monoxide readings during clinical evaluations.
The recalled units were distributed nationwide to healthcare facilities and providers in Pennsylvania, Utah, Texas, Florida, Massachusetts, and Iowa. Approximately 2160 units are affected, identified by lot number C20206 (231220).
The recalled product
- Product
- Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
- Manufacturer
- Capnia Inc
- Hazard
- residual-carbon-monoxide
- volatile-organic-compounds
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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