Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
- Recall date
- February 14, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1404-2025
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD, Inc.
- Sold / distributed
- US Nationwide distribution. International distribution pending.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
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