BEUDAMED
    FDA Recall Open, Classified

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    Recall: Z-1405-2025 · Initiated February 14, 2025

    Recall

    Recall Number
    Z-1405-2025
    Event Number
    96238
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    CCK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 14, 2025
    Posted
    March 20, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    Reason

    Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

    Action

    On February 14, 2025, customers were notified via Urgent Medical Device Correction letters. Consignees were instructed to locate and quarantine all affected product within their institution and destroy them. The recalling firm will contact customers who have returned completed response forms identifying affected products within their possession to discuss credit.

    Distribution

    US Nationwide distribution. International distribution pending.

    Quantity

    175,994 US; 45,223 OUS