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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems."
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¿…
- 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
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