Notes

Avanos Medical Announces Recalls of the Cortrak*2 Entry Access System
Avanos Medical (U.S. Food & Drug Administration) has announced that it will be recalling Cortrak*2's enteral access system. The recall was announced due to patient injuries and deaths resulting from the misplacement of nasoenteric/n tubes. The recall includes 629 devices in use throughout the United States.

feeding tube placement Avanos markets the Cortrak*2 enteral access system for its ability to visualize the patient's small bowel and stomach, which helps in the placement of a medical feeding tube. Incorrectly inserting a tube can cause damage to the vocal cords, lungs , and trachea. 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 Avanos Medical has reported that there have been more than more than 23 deaths and 60 injuries caused by misplacement of the nasogastric feeding tubes with the CORTRAK*2 Ental Access System. Cortrak 2 eternal access system Avanos Medical Pulmonary failure, pneumothorax (collapsed lung tissue) perforation (a hole in one's esophagus or bowel wall) pneumonia, excessive fluid that is accumulating between the lung and chest cavity (the chest cavity and lungs) are all among the incidents.

Avanos Medical outlined a plan that would allow users to be updated with labeling so that they are able to confirm the position of nasogastric and other tubes prior to when they are used

Avanos is the FDA's second warning regarding inserting feeding tubes. Cortrak 2 eternal access system https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ In February, the FDA issued a warning for parents and healthcare professionals regarding the risk of strangulation when children are fed through feeding tubes. Avanos Medical Two child strangulation deaths were reported in 2021, the result of a tubing device that was wrapped around the neck of a patient.

FDA Recalls Avanos Medical Device

The potential risk of Enteral Feeding Delivery Sets

Cortrak* 2 Enteral Access System Product Details

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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