Smiths Medical Recalls BCI Remote Alarm Cables for Capnograph Systems
Smiths Medical is recalling 39 BCI Remote Alarm Cables because they may fail to transfer alarm signals to remote nurse alarm systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in critical environments where failure to transfer alarm signals poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 39 units of the BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers WW3398NO & WW3398NC. These cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the capnography system to a remote alarm system. The affected lot numbers are WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, and WW3398NC0947.
The recall is being issued because, in rare instances, the BCI Remote Alarm Cables are not transferring alarms when used with some remote nurse alarm systems. The products were distributed nationwide in the United States, including in the states of Colorado, Illinois, Indiana, Massachusetts, South Carolina, and Wisconsin.
The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. Users should contact Smiths Medical ASD, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿ Capnograph
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: WW3398NO0820
- WW3398NO0847
- WW3398NO0948
- WW3398NC0822
- WW3398NC0847
- WW3398NC0947.
Distribution
Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12