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Avanos Medical Recalls Cortrak*2 Enteral Access Systems
Avanos Medical (U.S. Food & Drug Administration) has announced it will recall Cortrak*2's Enteral access system. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system The recall was initiated in response to injuries sustained by patients and deaths resulting from the misplacement of nasoenteric/n tubes. Avanos Medical The recall covers 629 devices which were distributed throughout the United States.

Avanos is promoting the Cortrak*2 Ental Access System because of its ability to view the stomach and small bowel. This permits the placing of an medical feed tube. Patients may however be harmed to their vocal cords or their lungs if the tube was not properly placed. https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos Medical recalls that there are 60 injuries, 23 deaths and 23 illnesses resulting from the incorrect placement or accidental insertion of a nasogastric feeding tube using the CORTRAK*2 Entral Access System. Pneumothorax (collapsed lung) and pneumothorax. Perforation (a gap or hole within the wall of a lung), pneumonia, and the pleural effusion (excess liquid in the chest cavity and the lungs) are just a few incidents.

Avanos Medical described a plan for users to receive updated labels to ensure proper positioning of the nasogastric tubes and nasoenteric pipe prior to use.

Cortrak 2 eternal access system Avanos is the second alert that the FDA has issued regarding intra-oral feeding tubes. In February the FDA issued a warning for parents and healthcare providers regarding the possibility of strangulation if children are fed by feeding tubes. Two cases of strangulation in children occurred in 2021. It was caused by the tubing system that was that was wrapped around the neck of the patient.

Avanos Medical feeding tube FDA Recalls Avanos Medical Device

The potential risks of entering Feeding Delivery sets

Cortrak* 2 Enteral Access System Product Details

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