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Avanos Medical and FDA issued a Class 1 recall of 629 units CORTRAK*2 the enteral access system. It is a feeding tube placement device that is linked to many incidents of injury and death.
These devices were distributed between April 1st of 2016 between January 1st, 2022 and April 1, 2016. Avanos Medical Avanos Mediacal Cortrak 2 These devices can be utilized by healthcare professionals to place feeding tubes in the stomach or in the intestines.
Since 2015, there have been 23 deaths and 60 injuries reported due to nasogastric and nasoenteric tubes that were placed incorrectly.
This recall will be used to change the information on the device to remind users to verify that the tube is correctly placed before they can deliver nutrition.
Avanos Medical feeding tube According to FDA the adverse events were respiratory failure, pneumothorax (collapsed lung) perforation (a hole in the wall or bowel of the lungor bowel of the lung (a lung infection), and the pleural effusion (excess liquid that has accumulated in the lung space and the chest cavity).
Avanos Medical feeding tube Avanos Medical 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].
Homepage: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery
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