Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal.

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