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.