Smiths Medical ASD, Inc.: Device Recall

Recall #Z-1404-2025 · 02/14/2025

Class II: Risk

Recall Details

Recall Number: Z-1404-2025
Classification: Class II
Product Type: Device
Recalling Firm: Smiths Medical ASD, Inc.
Status: Ongoing
Date Initiated: 02/14/2025
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 175,994 US; 45,223 OUS

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.

Product Description

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Distribution Pattern

US Nationwide distribution. International distribution pending.

Other Recalls by Smiths Medical ASD, Inc.

Class I: Dangerous 04/10/2025

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Class I: Dangerous 04/10/2025

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Class I: Dangerous 04/10/2025

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Class I: Dangerous 04/10/2025

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Class I: Dangerous 04/10/2025

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

View all recalls by Smiths Medical ASD, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.