Pedi Cap Carbon Dioxide Detector Recall
The FDA has notified healthcare providers of a class 1 recall for Covidien Pedi-Cap End-Tidal CO2 detectors for a design defect that could cause death to infants that are hospitalized. The most serious type of recall by the Food and Drug Administration are Class 1 recalls and they include circumstances where there is a large probability that the use of the products will cause serious injury or death. 80 lots of the Pedi-Cap End-Tidal CO2 Detector are affected by the recall. The affected detectors were manufactured from November 1st of 2008 through July 24th of 2009 and they were distributed from the November 1st, 2008 through July 31st, 2009. The model numbers that were affected can be found in the FDA’s recall notice.
The Pedi-Cap Detector is used during the procedure of exchanging oxygen for carbon dioxide in pediatric patients that weigh between 2.2 and 33 pounds. The doctor or health care provider manually inserts a tube from the device into the child’s windpipe.
The Pedi-Cap End-Tidal CO2 Detector may make the resistance of the flow of air into the lungs greater, according to the Covidiens recall notice, resulting in the failure to verify the correct placement of a breathing tube when inserting it into the windpipe and ineffective ventilation. It is a great probability that using the PediCap will cause adverse health problems or death.
Covidien sent a letter to its distributers and customers on August 14th of 2009 informing to stop the use and selling of the devices that have been affected and return them to the company. Cocidien expects to have modified devices available by late September 2009.