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Pedi-Cap End Tidal CO2 Detector Recall Deemed Class I

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Covidien is recalling its Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6).  The Food & Drug Administration (FDA) has deemed this action a Class I recall, its most serious type.

This Pedi-Cap End-Tidal CO2 Detector is used in pediatric patients, weighing 2.2-33 pounds, during the process of exchanging oxygen for carbon dioxide (ventilation) in healthcare settings.  The recalled devices were manufactured November 1, 2008 through July 24, 2009 and distributed from November 1, 2008 through July 31, 2009. Only Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6) from the lot numbers listed here are included in this recall.

According to Covidien’s recall notice, the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. This problem may mimic the signs and symptoms of other medical conditions such as the presence of air or gas in the cavity of the membranes surrounding the lungs. There is a reasonable probability that use of the recalled PediCap will cause serious adverse health consequences or death.

On August 14, 2009, Covidien sent a letter to their distributors/customers informing them to stop selling/using the affected devices and to return them to the company. The company has taken steps to resolve this problem and expects to have modified devices available by the end of September, 2009.

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