FDA-Device2025-03-26Class II
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Smiths Medical ASD, Inc.
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.
Sold states
US Nationwide distribution. International distribution pending.
Affected count
175,994 US; 45,223 OUS
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1404-2025Don't want to check this manually?
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