Notes

Avanos fails to meet FDA Class 1 Recall Due to 23 Deaths in Connection with the Device
Avanos Medical Cortrak*2 Enteral Access System is designed to assist medical professionals who are trained to insert medical feeding tubes in the small bowel or stomach of patients who require to get nutrition through the tube. In 2015, however, 23 people have died from complications related to the feeding tube.

Patients have suffered fatalities and injuries due to incorrect placement of nasoenteric/nasogastric tube devices.

Avanos Medical This recall is used to change the labeling of the device as well as the instruction and intended uses. These changes require that users verify tube placement as per the guidelines of their institution before making use of the tube to distribute nutrients.

Avanos Medical Patients can suffer serious injuries or even die in the event that a nasogastric tube, or nasoenteric tub has been incorrectly placed.

Avanos Mediacal Cortrak 2 Avanos Medical's recall notice stated that there were 60 injuries and 23 deaths due to the misplacement or removal of the nasogastric feed tube during usage of the CORTRAK*2 Entral Access System. This occurred from the year 2015. Pneumothorax (collapsed lung) also known as pneumothorax ("collapsed lung"), perforation ("hole in the wall or the bowel of the lung), pneumonia (a bacteria-related infection that affects the lung) and the pleural fluid (excess fluid between the lungs).

Cortrak 2 eternal access system Avanos Medical sent a field correction notice on March 21st 2022 to customers who utilized the devices between January 2021 and January 2022. The notice contained the following instructions:

Verify the placement of the nasogastric, nasal and other tubes according with institutional policies.
Attach the field correction notice about the issue to the operator's guide.
Avanos will be required to acknowledge the receipt of the email notification. Avanos Mediacal Cortrak 2
Homepage: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/