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Avanos Medical, FDA and the FDA have issued a Class 1 Recall for about 629 units of CORTRAK*2's Ental Access System. Avanos Medical Cortrak 2 eternal access system This feeding tube positioning device has been associated with numerous injuries and deaths.
These devices were introduced between April 1st of 2016 to January 1, 2022. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube These devices can be utilized by health professionals to put feeding tubes into the stomach or intestines.
Since 2015, there's been 20 deaths and 60 injuries recorded due to nasogastric and nasoenteric tubes that were not placed correctly.
The recall is being used to change the device's label to instruct users to verify that the tube has been placed correctly before delivering nutrition.
Avanos Medical "Adverse events reported included respiratory failure as well as pneumothorax (collapsed lung), perforation (a hole in the wall of the lung the esophagus, bowel, or stomach) and pneumonia (a lung infection) and an effusion of the pleura (excess fluid in the lung cavity and the chest cavity)," according to the FDA.
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].
Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/
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