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Avanos fails to meet FDA Class 1 Recall Resulting in 23 Deaths in Connection with the device
Avanos Medical Cortrak 2 Entry Access Systems is created to assist trained healthcare professionals to insert medical feed tubes in the stomach or small bowel of patients who require nutrition. Avanos Mediacal Cortrak 2 However, since 2015, there have been 23 deaths related to the feeding tube.

Patients have been killed and injured as a result of misplacement of nasoenteric/nasogastric tube placement devices.

This recall is utilized to create updates to the device's labeling. This includes the directions for use and intended uses. The updated instructions instruct users to check the placement of the tube based on their institution's protocols before using the tube for delivering nutritional supplements.

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Patient's vocal cords, lungs and the trachea can be damaged if the nasogastric/nasoenteric tube was installed improperly. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause This could cause serious injury or even death.

Avanos Medical has issued a recall notification stating that, since 2015, there have been 60 deaths of patients and 23 injuries resulting from misplacement nasogastric feeding tube. There have been several adverse events, such as respiratory failure, pneumothorax (collapsed lungs), perforation (a hole or opening within the wall of the esophagus or bowel) or pneumonia, as well as the pleural effusion (excess fluid in the space between your lungs and the chest cavity).

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. The notice provided the following guidelines:

Check the position of the nasogastric and nasoenteric and other tubes in accordance with institutional guidelines.
Avanos Mediacal Cortrak 2 Attach the correct field notice regarding the issue to your operator's manual.
Avanos Med will require you to return the acknowledgement sheet that was sent with your email notification. Cortrak 2 eternal access system
Website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/
     
 
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