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Avanos Medical and the FDA have issued a Class 1 recall for about 629 units of CORTRAK*2 Enteral Access System, a feeding tube placement device that is linked to dozens of injuries and deaths.
The devices were released between April 1, 2016, until January 1, 2022. These devices are utilized by healthcare professionals to place feeding tubes into the stomachs of patients or in the intestines.
https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ Cortrak 2 eternal access system Since 2015, there have been 20 deaths and 60 injuries reported due to nasogastric and nasoenteric tubes that were improperly placed.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ The recall is used to update the device's label , which instructs users to verify that the tube is placed correctly before delivering nutrition.
According to FDA, "Adverse events include pneumothorax, respiratory failure, perforation (a hole or puncture in the lung's wall, esophagus, or the bowel) and pneumonia, lung infection, and pleural effusion ("excess fluid between the lungs and chest cavity),"
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 Mediacal Cortrak 2 Avanos Medical
Read More: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/
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