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Avanos Medical and the FDA have issued a Class 1 recall for about 629 units of the CORTRAK*2 Entral Access System, a feeding tube placement device responsible for dozens of deaths and injuries.
Cortrak 2 eternal access system The devices for recall were made available between April 1, 2016 to January 1, 2022. Avanos Medical feeding tube These devices are employed by health professionals to insert feeding tubes into stomachs of patients or intestines.
Since 2015, there's been 23 deaths and 60 injuries recorded for nasogastric or nasal tubes that were placed incorrectly.
https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ This recall is utilized to rectify the information on the device so that it reminds users to ensure that the tube has been set before they can provide nutrition.
According to FDA, "Adverse events include pneumothorax, respiratory failure perforation (a hole or puncture in the lung wall, esophagus or the bowel), pneumonia, lung infection, and pleural effusion ("excess fluid between the lungs, and the chest cavity),"
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]. https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
Website: https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
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