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Avanos Medical and the FDA have issued a Class 1 recall for about 629 units of the CORTRAK*2 Enteral Access System, a feeding tube placement device linked to dozens of fatalities and injuries.
https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ These devices were introduced between April 1, 2016, to January 1, 2022. Cortrak 2 eternal access system These devices can be utilized by healthcare professionals to place feeding tubes in the stomach or in the intestines.
Nasogastric or Nasoenteric tubes that were not properly placed have led to the deaths of 23 people and 60 injury reports since 2015.
Avanos Medical feeding tube The recall serves to modify the label of the device so that it can instruct users to verify that the tube is correctly placed prior to feeding.
Avanos Medical According to FDA, "Adverse events include respiratory failure, pneumothorax perforation (a hole or puncture in the lung's wall, esophagus, or bowel), pneumonia, lung infection and the pleural effusion ("excess fluid between the lungs, and the 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]. Cortrak 2 eternal access system
Homepage: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
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