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Avanos Medical Cortrak*2 Enteral Access System is designed to aid medical professionals who are trained to insert medical feeding tubes in the small bowel or stomach of patients who need to be fed via the tube. There have been 23 deaths reported to date due to feeding tubes in 2015.
Numerous reports have shown that patients suffered trauma or even died when their nasogastric and nasoenteric tubes were not properly placed. This is despite the fact that this device was used to aid in their placement.
Avanos Mediacal Cortrak 2 This recall is used to update the device's labeling, including the instructions for use as well as the intended use. Avanos Medical Avanos Mediacal Cortrak 2 https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges The update instructs users to verify that the tube is set up according to the institution's protocol before using the tube for nutritional delivery.
If a nasogastric, or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, the lungs, or trachea, all of which could result in serious harm or even death.
Avanos Medical recalls that there has been a total of sixty injuries and 23 deaths from the incorrect placement of nasogastric tubes in the last year. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Pneumothorax (collapsed lung) also known as pneumothorax ("collapsed lung"), perforation ("hole in the wall, or the bowel of the lung) as well as pneumonia (a bacteria-infected infection of the lungs) and the pleural fluid (excess fluid between the lungs.
On March 21 2022 Avanos Medical issued a field correction notification to its customers who used these devices between January 2021 and January 2022. The notice provided the following information:
Use nasogastric or Nasoenteric tubs according to the policies of the institution.
Cortrak 2 eternal access system Attach the corrected field notice relating to the problem to the operator's manual.
Avanos Med will require you to return the acknowledgement sheet that was sent with your email notification. Avanos Mediacal Cortrak 2
Homepage: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
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