A design defect that could result in the death of hospitalized infants has led the FDA to notify healthcare providers about a Class I recall for Covidien Pedi-Cap End-Tidal CO2 detectors.
The recall applies to 80 lots of the medical devices used in pediatric patients during the process of exchanging oxygen for carbon dioxide. The recall has been classified by the FDA as Class I, meaning that there is a reasonable probability that use of the device will result in serious injury or death.
The Pedi-Cap CO2 (carbon dioxide) detectors are designed to help with exchange of oxygen for carbon dioxide during ventilation. It is used for infants weighing between 2.2 and 33 pounds in a hospital setting, with a doctor or other healthcare provider manually inserting a tube from the device into the child’s windpipe.
The FDA and Covidien warn that some of the Pedicaps have a design flaw that can result in improper intubation, and could actually hinder the child’s breathing instead of aiding it. In these circumstances, the device may not alert medical staff that there is a problem, and the source of the infant’s breathing problems may not be identified. Breathing problems caused by the device may closely resemble other problems, such as air or gas in the chest cavity surrounding the lungs.
The recall affects 80 lots of the Pedi-Cap End-Tidal CO2 Detector. They were manufactured from November 1, 2008 through July 24, 2009 and distributed from November 1, 2008 through July 31, 2009. A list of model numbers affected by the recall is available in the FDA’s recall notice.
In August, Covidien sent a letter to distributors and healthcare professionals to stop selling or using the items and to return them to the company. The devices will be replaced by a modified version which should be available by the end of this month.