The U.S. Food and Drug Administration has classified Covidien’s Aug. 4 voluntary recall of certain Shiley adult tracheostomy tubes as a Class I. Class I recalls are the most serious because the products in question have the potential to cause severe injury or death.
Covidien recalled some of these tubes because of leakage and/or “disconnection between the inner and outer cannulae, which were observed during mechanical ventilation of patients,” the agency said on Wednesday. A tracheostomy tube, prescribed by a physician, is used to create a pathway to drain fluid from the lungs and trachea.
The affected products were manufactured between Oct. 1, 2009 and June 26, 2012. Covidien is advising customers to return all the defective products and, if one is being used in a patient, to have that be replaced as soon as clinically advisable. However, if the physician determines the product needs to stay in, then Covidien recommends increased monitoring of the patient.
