Recall Z-1405-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-1405-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-14

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-02-14. It names one FDA 510(k) clearance: K941982. Product: CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214. Reason: 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..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-14
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K941982 — CAPNOCHECKBci, Inc.·cleared 1994-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.