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.
You may also be interested in...
Alere aided by professional diagnostics sales in fourth quarter
Alere’s professional diagnostics business helped the firm record overall revenue growth in the fourth quarter of 2010, offsetting a fall in influenza-based sales in North America.
Integra and Stout to work on expandable interbody device
Integra LifeSciences has gained exclusive worldwide rights from Stout Medical to develop and commercialise an expandable interbody fusion device.
Gen-Probe eyes portfolio expansion to help boost molecular diagnostics credentials
Gen-Probe recently launched its Panther automated molecular diagnostics system in Europe with the aim of bringing another dimension to its product portfolio. Joseph Harvey met the firm’s CEO, Carl Hull, at the launch of the product in Frankfurt to find how high the firm has set its sights in the molecular diagnostics sector and how it is going to achieve its goals