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Avanos Medical and the FDA have issued a Class 1 recall for approximately 629 units of the CORTRAK*2 Entral Access System, a feeding tube device that has been responsible for dozens of injuries and deaths.
https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas Avanos Medical feeding tube The devices that were recalled were released between April 1, 2016 and January 1, 2022. Avanos Medical feeding tube These devices are used by healthcare professionals to insert feeding tubes into the stomachs of patients or intestines.
Avanos Medical Nasogastric or Nasoenteric tubes that were not properly placed have led to 23 deaths and 60 injury reports since 2015.
The recall is utilized to modify the label of the device, which will instruct users to ensure that the tube has been properly placed prior to delivering food.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause According to FDA, "Adverse events include pneumothorax, respiratory failure, perforation (a hole or puncture in the lung's wall, esophagus or the bowel) or pneumonia, lung infection, and pleural effusion ("excess fluid that is accumulating 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.igj.nl/binaries/igj/documenten/waarschuwingen/2022/05/11/avanos-medical-fca-2022-002---cortrak-2-enteral-access-system-eas/IT2061269+Avanos+FCA-2022-002+-+Cortrak+2+Enteral+Access+System+(EAS).pdf
Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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