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Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Recalled March 26, 2025 · FDA recall Z-1405-2025 · Smiths Medical ASD
Hazard
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. · FDA Class II
Units
175,994 US; 45,223 OUS
Sold at
US Nationwide distribution. International distribution pending.
Description
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.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Manufacturer(s)
Smiths Medical ASD, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →