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Avanos Medical Cortrak*2 Ental Access System is designed for trained health professionals to place medically-approved feeding tubes into the stomach or small bowels of those who require nutritional support. However, since 2015, there have been 23 deaths related to feeding tubes.
There have been many incidents of death and injuries from patients who have had their nasogastric tubes misplaced.
This recall is used for updates to the labeling of the device and instructions to use. These updates require users to verify tube placement as per the guidelines of their institution before making use of the tube to deliver nutrients.
Avanos Medical Patient's vocal cords, lungs, and the trachea may be damaged if the nasogastric/nasoenteric tube was inserted incorrectly. Avanos Medical This could cause serious injury or even death.
Avanos Medical's recall communication said that there were sixty injuries, 23 deaths, and 58 patients injured by the misplacement of the nasogastric tubes. Cortrak 2 eternal access system The CORTRAK*2 enteral access device has been in use since the year 2015. There were several adverse events, such as respiratory failure pneumothorax (collapsed lung tissue), perforation (a hole or opening within the esophagus's wall or the bowel), pneumonia, and the pleural effusion (excess liquid in the space between your lungs and the chest cavity).
Avanos Medical Avanos Medical sent a field correction notice on March 21st 2022 to customers who utilized the devices between January 2021 and January 2022. The following instructions were contained in the notice:
Confirm placement of the nasogastric and nasoenteric and other tubes in line with institutional policies.
Attach the updated field notice relating to the problem to the operator's guide.
Cortrak 2 eternal access system Avanos Med will ask that you return the acknowledgment sheet that was sent with the email notice. Cortrak 2 eternal access system
My Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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