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The Food and Drug Administration (FDA) today 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.
The probe is believed to have caused a life-threatening infection in 11 children in intensive care units at Childrens Medical Center in Dallas. Two children died following use of the probe and investigation into the actual cause of their deaths is ongoing.
The children were identified as being infected with Burkholderia cepacia, a bacteria known to cause infections in intensive care unit patients and associated with the use of contaminated equipment and solutions.
Eight of the children had been part of a research study sponsored by Nellcor to test the safety and effectiveness of the probes. The probes are also used for adults.
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 Nellcors facility in Tijuana, Mexico.
FDA first learned of a potential problem with the product when notified by the Texas Department of Health on Aug. 18, 2004. On Aug. 19, 2004 FDA sent an investigator to Nellcor Corporate headquarters in Pleasanton, Calif., to conduct an inspection, which is ongoing at this time.
On Aug. 24, 2004 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 http://www.fda.gov/medwatch/index.html.
Physicians and patients can obtain further details about the recall from Nellcor at (800) 635-5267, option 3.