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Avanos Medical, FDA and the FDA have issued a Class 1 Recall of approximately 629 units of CORTRAK*2's Ental Access System. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Cortrak 2 eternal access system This feeding tube device has been associated with numerous injuries and deaths.
https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ The devices were released between April 1st of 2016 and January 1, 2022. They're used to aid medical professionals insert feeding tubes in the stomach or the intestines and bowels of patients.
https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ Avanos Medical feeding tube Cortrak 2 eternal access system Cortrak 2 eternal access system Nasogastric or Nasoenteric tubes which were placed incorrectly have resulted in 20 deaths and 60 injury reports since 2015.
The recall will change the label on the device so that it can inform users to ensure that the tube has been properly placed prior to delivering food.
According to FDA the adverse events include respiratory failure as well as pneumothorax (collapsed lungs), perforation [a hole in the wall or bowel of the lung], pneumonia (a lung infection) and Pleural effusion (excess fluid in the lung space 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].
Homepage: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
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