Covidien’s Shiley Recall Now Becomes FDA Class 1

As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.

On August 6th we covered the voluntary recall by Covidien of some of its Shiley Adult Tracheostomy tubes as a response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

Now the recall has been made official by dint of FDA issuing a Class 1 recall notice which can be found here.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Source: FDA

published: August 16, 2012 in: Alerts/Adverse Events, Covidien, Thoracic/Respiratory

Covidien’s Shiley Recall Now Becomes FDA Class 1

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