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Avanos Medical and FDA issued a Class 1 recall of 629 CORTRAK*2 an enteral access device, which is a feeding tube placement device that has been implicated in numerous accidents and deaths.
Cortrak 2 eternal access system The devices that were recalled were released between April 1, 2016 and January 1, 2022. Avanos Medical They're used to assist healthcare professionals to insert feeding tubes into the stomach or the intestines in patients.
https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Since the year 2015, there have been 23 deaths and 60 injuries recorded due to nasogastric and nasoenteric tubes that were not placed correctly.
The recall is being used to change the label on the device to inform users to confirm that the tube was correctly placed before feeding.
Avanos Medical feeding tube According to FDA the adverse events include respiratory failure and pneumothorax (collapsed lungs) and perforation, a hole in the wall or bowel of the lungor bowel of the lung (a lung infection), and the pleural effusion (excess liquid in the space between your lungs and the chest cavity).
Avanos Medical feeding tube For more information, customers with questions or concerns about this recall should contact Avanos Medical by phone at 470-448-5444 or by emailing [email protected]. Avanos Medical feeding tube
My Website: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
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