TUESDAY, April 27 (HealthDay News) -- Covidien and the U.S. Food and Drug Administration have initiated a voluntary recall of certain lots of cuffed Shiley tracheostomy tubes and custom/specialty tracheostomy tubes because pilot balloon inflation assembly leaks result in the cuffs not holding air.
Covidien notified customers of the issue on April 13 via letter. The company is urging customers to check products in use and in inventory to determine whether they are in the affected lots. The company's news release lists affected lot numbers.
When a cuff cannot hold air, as is the case with the affected products, the unit may not be able to adequately create positive pressure in a patient's airway, which means ventilation will be negatively affected.
"This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death," according to the news release.