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U.S. Department of Health and Human Services

Medical Devices

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Nellcor CapnoProbe Sublingual Sensor

Class I Recall
Date Recall
Initiated

August 24, 2004

 

Product:

Nellcor CapnoProbe Sublingual Sensors, Models SLS-1 and SLS1-S.

 

Use:

The sensor is a non-invasive single-use device that is placed under the patient’s tongue to measure the sublingual carbon dioxide concentration.

 

Recalling Firm:

Tyco Healthcare/Nellcor
4280 Hacienda Drive
Pleasanton, CA 94588

 

Reason for Recall:

The recall was initiated following hospital reports of Burkholderia cepacia, a pathogenic bacterium, cultured both from samples from patients monitored with CapnoProbes, and from unused CapnoProbe sensors. A variety of other potentially pathogenic bacteria species were cultured from unused CapnoProbe sensors.

 

Public Contact:

Clinicians, patients or consumers with inquiries should contact the Nellcor technical services department at 1-800-635-5267.

 

FDA District:

San Francisco

 

FDA Comment:

Hospitals should discontinue use of the CapnoProbe Sublingual Sensors and return any unused inventory to Nellcor. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 

 

 

For additional information on this product recall, see the Nellcor Press Release.

Also, see the FDA press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108344.htm

 

  Also, for additional information on this product recall, see the FDA Enforcement Report.