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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 feeding device that has been implicated in numerous injuries and deaths.
Avanos Medical The devices were made available between April 1st, 2016 until January 1, 2022. Avanos Medical These devices can be used by health professionals to insert feeding tubes in the stomach or intestines.
https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos Medical Cortrak 2 eternal access system Nasogastric tubes or Nasoenteric tubes that were incorrectly placed have caused more than 60 injuries and 23 deaths incidents since 2015.
This recall will be used to correct the information on the device in order to remind users to check that the tube was properly set before they can provide food.
"Adverse instances reported were respiratory failure or pneumothorax (collapsed lung) and perforation (a hole in the wall of the lung or esophagus or bowel) and pneumonia (a lung infection) and an effusion of the pleura (excess fluid in the lung cavity and chest cavity)," according to the FDA.
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].
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
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