FDA and Tyco Healthcare/Nellcor notified consumers and
healthcare professionals of a Class I recall for all
of its CapnoProbe Sublingual Sensors, a device similar
to an electronic thermometer that is used by hospitals
to measure the carbon dioxide in patients' tissues. The
probe and associated saline contain the bacteria Burkholderia
Cepacia and other opportunistic pathogens that can cause
serious infections, usually in persons who have decreased
resistance to infection.
Read the MedWatch 2004 safety summary, including links
to the FDA recall notice at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#capno