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The Avanos Medical Cortrak*2 Ental Access System was created to assist trained health professionals with the placement of medical feeding tubes into the small intestines of patients or stomachs. There have been 23 deaths reported up to date due to feeding tubes in 2015.
There have been numerous instances of injuries to patients and deaths resulting from misalignment or misplacement of nasogastric, or the nasoenteric tubes. Avanos Medical They are employed to assist in the placement of their tubes.
This recall is being used to update the labeling of the device that include the directions to use. Avanos Medical feeding tube The updates will require users to confirm the placement of the tube as per the guidelines of their institution before using the tube to provide nutrients.
The patient's vocal cords, lungs and the trachea can be damaged if the nasogastric/nasoenteric tube was placed incorrectly. Avanos Medical This could cause serious injury or even death.
Avanos Medical's recall notification said that there were 60 injuries and 23 deaths due to the misplacement or removal of the nasogastric feed tubes during using the CORTRAK*2 enteral Access System. This occurred from the year 2015. https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ Pneumothorax (collapsed lung) or pneumothorax ("collapsed lung"), perforation ("hole in the wall" or the bowel of the lung) and pneumonia (a bacteria-related infection that affects the lung) and pleural fluid (excess fluid between the lungs.
Cortrak 2 eternal access system On March 21, 2022, Avanos Medical issued a field correction notification to its customers who used these devices between January 2021 to January 2022. The notice included the following information:
Verify the placement of nasogastric/nasoenteric according to the institutional guidelines
Attach the corrective notice in the field in the operator's manual.
Avanos will be required to acknowledge the receipt of the email notification.
Homepage: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/
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