Date Recall Initiated |
August 24, 2004 |
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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/bbs/topics/news/2004/NEW01108.html |
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Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00865.html. Scroll down to "Recalls and Field Corrections: Devices - Class I". |
Updated September 24, 2004
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