The United States Food and Drug Administration (FDA) has posted a medical device safety alert issued by medical device manufacturer, Smiths Medical ASD, concerning its BCI Remote Alarm Cables (NO=Normally Open, NC=Normally Closed), used with 9004 the Capnocheck Capnography (Plus or Sleep) System, Reorder Numbers: WW3398NO & WW3398NC [Lot no.: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, and WW3398NC0947]. These cables were distributed in Colorado, Illinois, Indiana, Massachusetts, South Carolina, and Wisconsin from October, 2008 through September, 2012.
The BCI Remote Alarm Cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System to transfer alarm signals from the Capnocheck Capnography System to a remote alarm system.
The manufacturer has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death.
According to FDA, the manufacturer has notified its customers by an "Urgent Medical Device Field Safety Notice-Recall" Letter to instruct customers to inspect their inventory and remove all affected devices from use.
For details, please visit the following FDA website:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm347193.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 April 2013