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FDA NEWS RELEASE


FOR IMMEDIATE RELEASE
P04-82
August 27, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

 

Updated Version: Note this is an updated version of FDA PRESS RELEASE (P04-82, August 26, 2004). That release incorrectly stated that the recalling company had sponsored a clinical trial of this product at Children's Medical Center in Dallas. We regret this error.

FDA Announces Nationwide Recall of Nellcor Puritan Bennet Probes Device

FDA announced that Nellcor Puritan Bennett (Tyco Healthcare/Mallinckrodt) is conducting a nationwide recall of all of its CapnoProbes, a device similar to an electronic thermometer that is used by hospitals to measure the carbon dioxide in patients' tissues. Each probe is packaged in a metal canister filled with a saline solution and sealed in a foil envelope labeled as non-sterile. All of the CapnoProbes were manufactured at Nellcor's facility in Tijuana. Mexico. 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.

FDA first learned of a potential problem with the product when notified by the Texas Department of Health on August 18. Positive cultures were found in at least 11 patients in the pediatric intensive care units of Children's Medical Center in Dallas. An association with these specific culture findings and patient outcomes has not been established at this time. On August 19, FDA sent an investigator to Nellcor Corporate headquarters in Pleasanton, Calif., to conduct an inspection, which is ongoing.

On August 24, Nellcor notified its customers that they were recalling all lots of the CapnoProbe SLS-1 Sublingual Sensors and asked hospitals to return any unused inventory. The firm said the probe may pose a hazard to patients with compromised immune systems. Both FDA and Nellcor Puritan Bennet are continuing their investigations.

Healthcare facilities that are aware of deaths or injuries related to use of the CapnoProbe should report them to Nellcor and to the FDA through the MedWatch program at www.fda.gov/medwatch/index.html

Physicians and patients can obtain further details about the recall from Nellcor at 1-800-635-5267, option 3.

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