Smiths Medical faces FDA Class I recall over sleep alarm cables

The FDA slapped Smiths Medical with a Class I recall over cables the company makes for its Capnocheck Capnography sleep alarm systems, which nurses uses to monitor patients remotely. Regulators say that in some cases, the offending BCI remote alarm cables don't transfer the alarms properly, which can put patients at risk of death or other health problems. Smiths Medical initiated the recall on Feb. 6, 2013, and has notified customers about the problem with an "Urgent Medical Device Field Safety Notice – Recall" letter, regulators explain. Smiths distributed the offending cables in Colorado, Illinois, Indiana, Massachusetts, South Carolina and Wisconsin from October 2008 through September 2012. FDA notice

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