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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 associated with dozens of accidents and deaths.
https://www.fcc.gov/fcc-bin/bye?https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ Avanos Medical Avanos Mediacal Cortrak 2 The devices affected were distributed between April 1 2016, 2016 until January 1, 2022. The devices are utilized by healthcare professionals to insert feeding tubes into stomachs of patients or their intestines.
Nasogastric or Nasoenteric tubes which were placed incorrectly have resulted in more than 60 injuries and 23 deaths reports since 2015.
https://app.glosbe.com/profile/7061070846214802652 The recall is used to modify the label of the device, in order to make it clear to users that the tube is correctly placed prior to feeding.
https://dohabb.com/index.php?page=user&action=pub_profile&id=4283428 According to FDA, "Adverse events include respiratory failure, pneumothorax perforation (a puncture or hole in the lung's wall, esophagus, or the bowel) as well as pneumonia, lung infections, and the pleural effusion ("excess fluid between the lungs and 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].
Homepage: https://www.fcc.gov/fcc-bin/bye?https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
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