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According to the U.S. Food & Drug Administration (FDA), Avanos Medical is recalling the Cortrak*2 Enteral Access System due to misplacement of nasoenteric or nasogastric tubes has resulted in injuries and patient deaths. The recall covers 629 devices that were sold in the United States.
feeding tube placement Avanos has marketed the Cortrak*2 Enteral Access System for its interactive display of a patient's stomach , or small bowel, to aid in the proper positioning of a medical feed tube. However, patients may be harmed to their vocal cords or their lungs if the tube was not properly inserted. https://www.transtats.bts.gov/exit.asp?url=https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/ According to the Avanos Medical recall notice there have been 60 incidents of injury and 23 patient deaths since 2015 related to misplacement of feeding tubes for the nasogastric system using the CORTRAK* 2 Enteral Access System. Pneumothorax, pulmonary failure (collapsed lung tissue) perforation (a hole in the esophagus or bowel wall), pneumonia, and excess fluid between the lung and chest cavity (the chest cavity and lung tissue) are just a few of the injuries.
Avanos Medical describes a plan to change the labeling of its products to ensure proper placement of tubes for nasogastric and nasoenteric before use
The Avanos warning is the second caution the FDA issued in 2022 regarding the use of enteral feeding tubes. The FDA warned healthcare professionals and parents about the risk of strangulation among children who use feeding tubes. Two instances of strangulation in children involving feeding tubes wrapped around the necks of patients were reported before 2021.
FDA Recalls Avanos Medical Device
The Potential Risk of Enteral Feeding Delivery Sets
Cortrak* 2 Enteral Access System Product Details
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