Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Summary
The FDA issued a Class II for Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Mo by Capnia Inc. Reason: Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present.
Details
Source
Device Recall
External ID
Z-2198-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Lot/Code Info: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
Quantity Affected: 2160
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-21
Company
Foster City, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Capnia Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Capnia Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Capnia Inc have FDA actions?
Capnia Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2198-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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