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Avanos Medical and the FDA have issued a Class 1 recall for approximately 629 units of CORTRAK*2 Enteral Access System, a feeding tube placement device responsible for dozens of fatalities and injuries.
https://washingtonindependent.com/deadliest-fda-recalls-2022-misplaced-feeding-tubes-leading/ The devices were made available between April 1, 2016 to January 1, 2022. https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its The devices are employed by health professionals to insert feeding tubes into patients' stomachs or intestines.
Cortrak 2 eternal access system Nasogastric or Nasoenteric tubes that were not properly placed have led to more than 60 injuries and 23 deaths reports since the year 2015.
Cortrak 2 eternal access system This recall will be used to update the label on the device to remind users to verify that the tube has been placed before they can deliver nutrition.
Avanos Medical feeding tube https://medicaldevices.icij.org/events/hkg-cortrak-2-enteral-access-system-eas According to FDA the adverse events include respiratory failure as well as pneumothorax (collapsed lungs) perforation (a hole in the wall or bowel of the lung], pneumonia (a lung infection), and Pleural effusion (excess liquid in the lung space 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].
Website: https://washingtonindependent.com/deadliest-fda-recalls-2022-misplaced-feeding-tubes-leading/
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