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Avanos is facing FDA Class I Recall after 23 Deaths Associated with Device

 Avanos Medical Cortrak*2 Enteral Access System is designed to help healthcare professionals with training to insert medical feeding tubes in the stomach or small bowel of patients who have to get nutrition through the tube. There have been 23 deaths related to feeding tubes since 2015. Avanos Medical Patients have died and injuries as a result of misplacement of nasoenteric/nasogastric tube placement devices. This recall is being utilized to make changes to the labeling of the device, which includes the instructions for use. The updated instructions instruct users to confirm that the tube was installed according to their institution's guidelines prior to using the tube for nutritional delivery. Cortrak 2 eternal access system Patient's vocal cords, lungs, and trachea could be damaged in the event that the nasogastric/nasoenteric inserted in a wrong way. Cortrak 2 eternal access system This could cause grave injury or even death. Avanos Medical has issued a recall communication stating that since 2015, there has been 60 deaths of patients and 23 injuries caused by misplacement nasogastric feeding tube. There were several adverse events, including respiratory failure and pneumothorax (collapsed lung tissue) as well as perforation (a hole or opening within the esophagus's wall or bowel) or pneumonia, as well as the pleural effusion (excess fluid in the air space between your lungs and your chest cavity). Cortrak 2 eternal access system https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Avanos Medical sent a field correction notice on March 21st 2022 to customers who utilized the devices between January 2021 & January 2022. These instructions were included in the notice: Place nasogastric or nasoenteric tubs according to institution policies. Avanos Medical Attach the corrective notice in the field of the operator's handbook. Avanos Medical will provide the acknowledgement form included in the emailed notice. https://dailyhornet.com/2022/feeding-tube-placement-devices-recalled-after-23-deaths-reported/ Avanos Medical feeding tube

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