Notes

Avanos Medical recalls the Cortrak*2 entry access system
Avanos Medical is recalling Cortrak*2 Entry Access System. The FDA states that patients have been injured and even killed by nasogastric and nasoenteric tube misplacement. The recall covers 629 devices sold in the United States.

Avanos is promoting the Cortrak*2 Ental Access System because of its ability to view a patient's stomach and small bowel. This allows for the placing of a medical feed tube. If a tube is placed improperly the patient could suffer damage to their vocal cords, lungs, or the trachea. According to the Avanos Medical recall communication, there were 60 incidents of injury and 23 patient deaths since 2015 related to misplacement of feeding tubes for the nasogastric system using the CORTRAK* 2 Enteral Access System. Pneumothorax (collapsed lung), pneumothorax, perforation (a hole or opening in the lung's wall), pneumonia, and the pleural effusion (excess liquid between the chest cavity and the lungs) are just a few incidents.

feeding tube placement Avanos Medical described a plan for patients to receive a new labels to ensure proper placement of the nasogastric tubes and nasoenteric tubes prior to use.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 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 Avanos was the second alert that was issued by the FDA in 2022 regarding the use of enteral nutrition tubes. The FDA sent out a message to parents and healthcare providers concerning the risk of strangulation when feeding tubes are being used by children. Two deaths from child strangulation was reported in 2021 as a result of tubes that were placed around the neck of a patient.

https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ FDA Recalls Avanos Medical Device

Risk of entering feeding delivery sets

Cortrak* 2 Enteral Access System Product Details

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