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Avanos Medical and the FDA have issued a Class 1 recall for approximately 629 units of CORTRAK*2 Enteral Access System, a feeding tube device that has been linked to dozens of injuries and deaths.
The devices were released between April 1st of 2016 until January 1, 2022. The devices are used by healthcare professionals to place feeding tubes in the stomach or in the intestines.
Nasogastric tubes or Nasoenteric tubes that were incorrectly placed have caused 23 deaths and 60 injury reports since the year 2015.
feeding tube placement The recall is used to alter the label on the device to inform users to make sure that the tube is properly set up prior to feeding.
http://www.drugoffice.gov.hk/gb/unigb/www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ According to FDA adverse events, they include respiratory failure or pneumothorax (collapsed lung tissue) and perforation, a hole in the bowel or wall of the lungas well as pneumonia (a lung infection), and the pleural effusion (excess liquid in the lung space and your chest cavity).
https://www.ted.com/profile Avanos Mediacal Cortrak 2 For more information, customers with questions or concerns about this recall should contact Avanos Medical by phone at 470-448-5444 or by emailing [email protected]. Avanos Medical feeding tube
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