Avanos Medical and the FDA have issued a Class 1 recall for about 629 units of the CORTRAK*2 Enteral Access System, a feeding tube placement device that is linked to dozens of injuries and deaths.
The recalled devices were distributed between April 1, 2016 and January 1, 2022. They are used to help healthcare professionals place feeding tubes into the stomach or intestines of patients.
Since 2015, there have been 23 deaths and 60 injuries reported when nasogastric or nasoenteric tubes were placed incorrectly.
The recall is being used to update the device’s label to instruct users to confirm that the tube has been placed correctly before delivering nutrition.
“Adverse events reported included respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus, or bowel), pneumonia (a lung infection), and pleural effusion (excess fluid in the space between the lungs and the 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 firstname.lastname@example.org.