FDA recall Z-1405-2025

Smiths Medical ASD, Inc. · Class II · device

Product

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

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.

Distribution

US Nationwide distribution. International distribution pending.

Key facts

Status
Ongoing
Initiation date
2025-02-14
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1405-2025