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Avanos has been recalled by FDA Class I after 23 deaths related to device
The Avanos MedicalCortrak*2 enteral access system is designed to allow trained health care workers to insert medical feeding tubes in the small intestine or stomach of patients that require nutritional assistance. Since 2015, there have been 23 deaths attributed to the feeding tube.

There have been many reports of patients suffering injuries and even deaths following misplacement or misalignment of nasogastric, also known as nasal, or nasoenteric tube. Avanos Medical Cortrak 2 eternal access system They are used to assist in the placement of their tubes.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Avanos Medical This recall is being used for updates to the device’s labeling that include the directions on how to use it. The updates will require users to verify tube placement in accordance with the protocols of their institution before using the tube to deliver nutrients.

Avanos Medical feeding tube Patient's vocal cords, lungs and the trachea can be damaged when the nasogastric/nasoenteric tube is placed incorrectly. This can result in serious injury or even death.

Avanos Medical's recall notice declared that there were more than 23 deaths and 60 injuries linked to the misplacement or removal of nasogastric feed tubes in the using the CORTRAK*2 enteral Access System. This occurred from the year 2015. Avanos Medical feeding tube Respiratory failure, pneumothorax perforation (a hole in the stomach stomach wall) and pneumonia were all reported.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Cortrak 2 eternal access system On March 21 2022 Avanos Medical issued a field correction notice to its customers who used these devices between January 2021 and January 2022. Avanos Medical These instructions were included in the notice:

Check the position of the nasogastric and nasoenteric and other tubes in line with institutional policies.
Attach the corrective notice in the field to the operator's handbook.
Avanos Medical will return the acknowledgment form that was included in the email notice.
Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/
     
 
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