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Avanos Faces FDA Class I Recall After 23 deaths attributed to the device
Avanos Medical Cortrak*2 enteral access system is designed to allow health care workers to insert medical feed tubes into the stomach or the small intestine of patients that require nutritional assistance. Avanos Mediacal Cortrak 2 The feeding tube has been linked to 23 deaths in the last year.

There have been numerous reports of patient injuries and deaths due to misalignment or misplacement of nasogastric, also known as the nasoenteric tubes. They are used to assist in the placement of their tubes.

feeding tube placement This recall is being used to update the device's labeling. This includes the instructions for use as well as intended uses. The update instructs users to confirm that the tube has been set up according to the institution's guidelines prior to using the tube for nutritional delivery.

Avanos Medical Patients could suffer serious injury or even death when a nasogastric tubing or nasoenteric tube is not correctly installed.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system Avanos Medical's recall notice said that there were sixty-three injuries and 23 deaths due to the misplacement or removal of the nasogastric feed tubes in the usage of the CORTRAK*2 Entral Access System. This occurred in the year 2015. Pneumothorax (collapsed lung), pneumothorax ("collapsed lung"), perforation ("hole in the wall" or the bowel of the lung) as well as pneumonia (a bacteria-infected infection of the lung) and the pleural liquid (excess fluid between the lungs).

Avanos Medical, on March 21, 2022, issued a corrective field notice to its customers who had used the products between January 2021-January 2022. The notice contained the following instructions:

Confirm the placement of Nasogastric tubes as well as nasoenteric tubes in accordance with the institution's policies.
Avanos Medical feeding tube Attach the correction note from the field explaining the issue to the operator's manual.
Return the acknowledgement form included along with the email notice to Avanos Medical
Homepage: https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
     
 
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