CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Reported: March 26, 2025 Initiated: February 14, 2025 #Z-1404-2025
Product Description
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Reason for Recall
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.
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units Affected
- 175,994 US; 45,223 OUS
- Distribution
- US Nationwide distribution. International distribution pending.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100. Recalled by Smiths Medical ASD, Inc.. Units affected: 175,994 US; 45,223 OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1404-2025.
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