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Avanos Medical Cortrak*2 enteral access system is created to permit trained health care workers to place medical feeding tubes in the small intestine or stomach of patients who require nutritional assistance. Avanos Medical feeding tube The feeding tube has been implicated in 23 deaths since the year 2015.
There have been many reports of injury and death in patients who have had their nasogastric tubes misplaced.
Avanos Medical feeding tube This recall is used for updates to the device’s labeling that include the directions for use. The new instructions advise users to confirm tube placement based on their institution's protocols prior to using the tube for delivering nutritional supplements.
Patient's vocal cords, lungs, and trachea could be damaged when the nasogastric/nasoenteric tube is placed improperly. This can result in grave injury or even death.
The recall notice from Avanos Medical said that there were 60 injuries and 23 deaths due to the misplacement or removal of the nasogastric feed tubes in the using the CORTRAK*2 enteral Access System. Avanos Medical This occurred in the year 2015. https://www.fcc.gov/fcc-bin/bye?https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ Adverse events reported included respiratory failure, pneumothorax (collapsed lung) perforation (a hole in the lung's wall, esophagus or bowel) and pneumonia (a lung infection), and an effusion of the pleura (excess fluid that has accumulated in the lung space and the chest cavity).
On March 21 2022, Avanos Medical issued a field correction notification to its customers who had used the devices between January 2021 to January 2022. The notice contained the following information:
Verify the placement of nasogastric as well as Nasoenteric tubes in accordance with institutional guidelines.
Attach the corrective notice in the field to the operator's handbook.
Avanos Medical feeding tube Avanos Med will ask you to return the acknowledgement sheet included with your email notification. feeding tube placement
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