BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2198-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2198-2025
    Event ID
    97184
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Capnia Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    April 21, 2025
    Classification Date
    July 29, 2025
    Address
    1101 Chess Dr, Foster City, CA, 94404-1102, United States

    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.

    Code Info

    Monitor UDI-DI: 00858481006017. Lot (C20206): 231220

    Distribution

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

    Quantity

    2160