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Avanos Medical and FDA issued a Class 1 recall of 629 units of CORTRAK*2 Enteral Access System, which is a tube for feeding device linked to many injuries and deaths.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ Avanos Medical The devices affected were distributed between April 1st 2016, 2016 until January 1, 2022. The devices are used by health professionals to insert feeding tubes into the stomachs of patients or intestines.
Avanos Medical Cortrak 2 eternal access system The incorrect placement of the nasogastric tube and Nasoenteric tube is the source of the deaths of 23 and injuries to 60 since 2015.
The recall will modify the label of the device to instruct users to verify that the tube is properly placed prior to delivering food.
According to FDA the adverse events include respiratory failure, pneumothorax (collapsed lungs) perforation (a hole in the wall or bowel of the lung], pneumonia (a lung infection) and Pleural effusion (excess fluid in the space between your lungs and your chest cavity).
https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ 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.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/
Read More: https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/
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