Select Covidien Shiley Tracheostomy Tubes Recalled

Covidien is recalling certain lots of its Shiley tracheostomy tubes and custom/specialty tubes among reports of leaks in the tubes' pilot balloons. If there are leaks in the balloons, the cuffs aren't able to hold air, causing ventilation to not work properly and possibly resulting in a 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 resident requires assisted mechanical ventilation. The FDA advises that these situations could result in serious injury or even death.

If you have purchased tracheostomy products with any of the affected lot numbers from ProMed, please call Janice at our corporate office for assistance with a replacement. Janice can be reached at 800-648-5190, x 7616.

To view the lot numbers being recalled, click here.