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U.S. Department of Health and Human Services

Safety

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Nellcor CapnoProbe Sublingual Sensors

Audience: Hospitals and risk managers

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.

[September 15, 2004 - Recall Notice - FDA]