FDA announced that Nellcor Puritan Bennett (Tyco Healthcare/Mallinckrodt) is conducting a nation-wide 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 Children's Medical Center in Dallas. Two children died following use of the probe and an 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 Nellcor's facility in Tijuana, Mexico.
FDA first learned of a potential problem with the product when notified by the Texas Department of Health on August 18, 2004. On August 19, 2004, FDA sent an investigator to Nellcor Corporate headquarters in Pleasanton, Calif., to conduct an inspection.
On August 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.
See your doctor if you or a loved one has experienced serious health problems because of the Nellcor sensor. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.*Source: U.S. Food and Drug Administration
- Medical Devices & Implants