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Avanos fails to meet FDA Class 1 Recall Resulting in 23 deaths attributed to the Device
The Avanos Medical Cortrak*2 Ental Access System was designed to assist healthcare professionals to insert medical feeding tubes into the small intestines of patients or stomachs. The feeding tube has been associated with 23 deaths since the year 2015.

Cortrak 2 eternal access system There have been numerous reports of patients suffering injuries and even deaths due to misalignment or misplacement of nasogastric, also known as nasal, or nasoenteric tube. These devices are utilized to assist in the placement of their tubes.

Avanos Medical This recall is used to make changes to the device's labels, including the instructions for usage and the intended use. Users are instructed to verify that the tube is set according to the protocols of their institution before making use of it to deliver food.

Patients may suffer serious injury or even death due to incorrectly placed nasogastric and nasoenteric tubes.

Avanos Medical's recall notification stated that there were 60 injuries and 23 deaths due to the misplacement or removal of nasogastric feed tubes in the usage of the CORTRAK*2 Entral Access System. This occurred from the year 2015. Respiratory failure, pneumothorax perforation (a hole in the stomach stomach or wall) and pneumonia were all reported.

On the 21st of March 2022, Avanos Medical issued a field correction notification to its customers who utilized these devices between January 2021 and January 2022. Cortrak 2 eternal access system The notice provided the following information:

Verify the placement of the nasogastric, nasal and other tubes in accordance with institutional policies.
Attach the relevant note of correction to the field in the operator's guide.
Avanos Medical Avanos Medical feeding tube Avanos Med will ask that you return the acknowledgment sheet that was included in the email notice.
Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
     
 
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