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Avanos Refuse to FDA Class 1 Recall Due to 23 deaths attributed to the device
The Avanos Medical Cortrak*2 Ental Access System was developed to aid trained health professionals with the placement of medical feeding tubes in the small intestines of patients' stomachs. 23 deaths have been reported up to date due to the feeding tubes since 2015.

There have been numerous reports of injuries and patient deaths following nasogastric or nasoenteric tubes are misplaced after the device is used to assist in their placement.

The recall was used to create revisions to the device’s labels with instructions for use and intended purpose. Users are instructed to verify that the tube is set according to the protocols of their establishment prior to using it to deliver nutrition.

Avanos Mediacal Cortrak 2 If a nasogastric or nasoenteric tube is placed incorrectly the patient could suffer damage to the vocal cords, lungs or trachea, all which can lead to serious harm or even death.

Cortrak 2 eternal access system Avanos Medical's recall notice declared that there were more than 23 deaths and 60 injuries due to the misplacement or removal of nasogastric feed tubes in the using the CORTRAK*2 enteral Access System. This occurred from 2015. Pneumothorax (collapsed lung) or pneumothorax ("collapsed lung"), perforation ("hole in the wall or the bowels of the lung) and pneumonia (a bacterial infection in the lungs) and the pleural liquid (excess fluid between the lungs).

Avanos Medical Avanos Medical, on March 21st, 2022, issued an correct field notice to customers who used these products between January 2021-January 2022. Avanos Mediacal Cortrak 2 The notice provided the following information:

Check the positioning of nasogastric and nasoenteric tubes according to institutional guidelines.
Attach the correct notice in the field regarding the issue to your operator's manual.
Avanos Medical Avanos must acknowledge the receipt of the email notification.
Here's my website: https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/
     
 
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