Some lots of Medtronic's Covidien Shiley tracheostomy tubes have been recalled, because they were formed with a wider-angle bend than standard models manufactured after Nov. 29, 2012, according to a press release.
The company began notifying customers of the recall in early May.
Medtronic initiated the recall following a number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.
Since Nov. 29, 2012, Shiley tracheostomy tubes were shipped into Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States of America.
The recall includes specific lots from the eight product lines that were manufactured after Nov. 29, 2012. That information can be found in the press release.
