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Avanos Medical and the FDA have issued a Class 1 recall for 629 units of the CORTRAK*2 Enteral Access System, a feeding tube placement device that is connected to numerous injuries and deaths.
The devices affected were distributed between April 1st 2016, 2016 until January 1, 2022. These devices can be utilized by healthcare professionals to insert feeding tubes in the stomach or the intestines.
Cortrak 2 eternal access system https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ Cortrak 2 eternal access system Incorrect placement of nasogastric and Nasoenteric tube is the source of 53 deaths and 60 injuries since 2015.
Cortrak 2 eternal access system The recall is used to alter the device's label to instruct users to make sure that the tube has been properly set up prior to feeding.
According to FDA the adverse events were respiratory failure as well as pneumothorax (collapsed lung), perforation [a hole in the wall or bowel of the lungand pneumonia (a lung infection), and Pleural effusion (excess liquid that has accumulated in the lung space and the chest cavity).
Avanos Medical feeding tube Avanos Medical 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 feeding tube
Website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery
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