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Covidien tracheostomy tube fault results in Class I recall of Cook product

This article was originally published in Clinica

Executive Summary

The FDA has given a Class I classification to Cook Medical’s recall of its Ciaglia tracheostomy sets and trays, which contain faulty tracheostomy tubes developed by Covidien, According to the recall notice, Cook's Ciglia Blue Rhino and Ciglia Blue Dolphin tracheostomy introducer sets and trays include the Covidien Shiley 6PERC or 8PERC tracheostomy tube, which have been reported to leak air. A tracheostomy tube is usually inserted into the windpipe through an opening in the neck, and is used to provide an airway for ventilation. Potential air leaks could result in inadequate ventilation and lead to serious injury or death. The affected products were distributed from 18 February to 27 April 2009. Covidien issued a recall of certain lots of its Shiley tubes in April.

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