Medtronic (NYSE: MDT) announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small 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.
You are here: Home / Food Recalls / FDA Press Releases / Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes
About The FDA
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Leave a Reply