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Avanos Medical and FDA issued a Class 1 recall of 629 units of CORTRAK*2 the enteral access system. It is a tube for feeding device linked to many incidents of injury and death.
Avanos Medical The devices were made available between April 1, 2016 until January 1, 2022. Cortrak 2 eternal access system https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause They're used to assist healthcare professionals insert feeding tubes into the stomach or intestines of patients.
Since 2015, there's been 20 deaths and 60 injuries recorded in cases where nasogastric tubes or nasoenteric were placed in a wrong way.
Cortrak 2 eternal access system The recall is used to change the label on the device, in order to inform users to ensure that the tube is properly placed prior to delivering food.
Avanos Medical feeding tube "Adverse events that were reported included respiratory failure or pneumothorax (collapsed lung), perforation (a hole in the wall of the lung the esophagus, bowel, or stomach) as well as pneumonia (a lung infection), and an effusion of the pleura (excess fluid in the lung's space and 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]. Avanos Medical
Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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