BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2198-2025 · Initiated April 21, 2025

    Recall

    Recall Number
    Z-2198-2025
    Event Number
    97184
    Firm
    Capnia Inc
    FEI Number
    3008614998
    Product Code
    CCJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 21, 2025
    Posted
    July 29, 2025
    Address
    1101 Chess Dr, Foster City, CA, 94404-1102

    Description

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

    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.

    Action

    Starting on 4/21/2025 Product Advisory and Voluntary Field Action emails were sent to customers who were told affected devices would be replaced. Customers with questions could contact the firm at 904-588-2986

    Distribution

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

    Quantity

    2160