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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nellcor Announces Nationwide Voluntary Recall of All CapnoProbe™ Sublingual Sensors

Contact:
Randy P. Krotz
Tyco Healthcare
314-654-5233

FOR IMMEDIATE RELEASE --Pleasanton, CA -- August 26, 2004 -- This week Nellcor, part of Mallinckrodt, a Tyco Healthcare company initiated a voluntary recall of the CapnoProbe Sublingual Sensor. The sensor is a non-invasive single-use device that is placed under the patient's tongue to measure the carbon dioxide level in the tissue. The recall was initiated following hospital reports of infections and the finding of Burkholderia cepacia, a pathogenic bacteria, in the buffered saline solution in which the probes are packaged. B. cepacia is an opportunistic pathogen in compromised individuals, particularly those with cystic fibrosis or chronic granulomatous disease. Symptoms include high fever, bacteriemia, rapid progression to severe necrotizing pneumonia and death. Other potentially pathogenic bacteria may also be present.

Nellcor tested inventory samples of the CapnoProbe sensor after a hospital recently alerted the company to a rise in infections stemming from Burkholderia cepacia first observed by the hospital among a group of pediatric patients since April 2004. Reports from the hospital indicated that CapnoProbe was used during the course of treatments on 11 of 13 patients infected. Two of the infected patients have since died -- one from heart failure and one from pneumonia. According to testing conducted by the Texas Department of Health, the organism B. cepacia was detected from both the CapnoProbe device and the patient isolates. It has not been confirmed whether the infection was responsible for the patients' deaths.

Nellcor is working closely with the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and other public health agencies to determine the definitive source of the bacteria.

"We are actively investigating and committed to taking whatever measures are necessary to ensure the safety of our products and the patients who use them," said David Sell, Nellcor president. "We are committed to determine the root cause of this matter and resolving it quickly."

Nellcor has shipped approximately 5,600 sensors since launching the product in the United States in January 2003, and the device is currently in limited use nationwide in 60 healthcare centers. The company is working closely with healthcare providers to recover the product.

Earlier this week, Nellcor contacted every healthcare provider by phone and facsimile that had received the affected product, providing information outlining the recall process, and notifying them to cease use of the product and return any inventory to Nellcor. The company has discontinued manufacturing the product until the root cause of the contamination has been determined and corrected. Clinicians, patients or consumers with inquiries should contact the Nellcor technical services department at 1-800-635-5267, option 3.

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