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Avanos Medical (U.S. Food and Drug Administration) has announced that it will be recalling Cortrak*2's Enteral access system. This recall was initiated due to patient injuries and deaths caused by misplaced nasoenteric/nasoga tubes. The recall covers 629 devices which were distributed throughout the United States.
Avanos promotes the Cortrak*2 Ental Access System due to its ability to visualize the stomach of a patient and their small bowel. This permits the placement of an medical feed tube. If a tube is inserted in a way that is not correct, patients could experience damage to their vocal cords, lungs or the trachea. Avanos Medical feeding tube Avanos Medical has reported that there have already been more than 23 deaths and 60 injuries related to misplacement in nasogastric feeding tubes using the CORTRAK*2 Ental Access System. Avanos Medical Avanos Medical Pneumothorax, pulmonary failure (collapsed lung tissue), perforation, (a hole in the esophagus or the bowel wall) as well as pneumonia and excessive fluid in the lungs (the chest cavity as well as the lungs) have all been among the traumas.
Avanos Medical describes a plan to change the labeling of its products to ensure proper placement of nasogastric or nasoenteric tube before use
Avanos was the second alert issued by the FDA in 2022 about the use of enteral nutrition tubes. Avanos Medical The FDA sent out a message to healthcare professionals and parents regarding the danger of strangulation when feeding tubes are used by children. Avanos Medical Two deaths resulting from strangulation of children took place in 2021 because of the tube being placed around the neck of a patient.
FDA Recalls Avanos Medical Device
Ental Feeding Delivery Sets
Cortrak* 2 Enteral Access System Product Details
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Read More: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
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