Covidien’s Shiley Recall Now Becomes FDA Class 1

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