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The Avanos Medical Cortrak*2 Ental Access System was created to assist healthcare professionals to insert medical feeding tubes into patients' small intestines or stomachs. https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ The feeding tube has been associated with 23 deaths since 2015.
There have been numerous reports of injuries to patients and deaths following misplacement or misalignment of nasogastric, or nasal, or nasoenteric tube. https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its These devices are used to assist in the placement of their tubes.
This recall is used to modify the device's labels, including the instructions for usage and intended uses. The new labeling instructs users to confirm that the tube was installed according to their institution's guidelines prior to making use of the tube for food delivery.
Patients can suffer serious injuries or even death if a nasogastric tube or nasoenteric tube is not correctly placed.
Avanos Medical Avanos Medical's recall notice declared that there were sixty-three injuries and 23 deaths linked to the misplacement or removal of nasogastric feed tube during usage of the CORTRAK*2 Entral Access System. Avanos Medical feeding tube This occurred since 2015. Pneumothorax (collapsed lung) or pneumothorax ("collapsed lung"), perforation ("hole in the wall, or the bowel of the lung) as well as pneumonia (a bacterial infection in the lungs) and pleural fluid (excess fluid that is accumulated between the lungs.
Avanos Medical issued a correction notice to those who purchased these devices between January 2021 to January 2022 on March 21, 2022. The notice contained the following instructions:
Verify the location of Nasogastric tubes as well as nasoenteric tubes in accordance with the institution's policies.
Attach the updated field notice relating to the problem to the operator's guide.
Avanos Health Medical requests that you return the acknowledgment form enclosed with the emailed notification Cortrak 2 eternal access system
My Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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