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Avanos Medical, FDA and Avanos Medical, FDA and the FDA have issued an Class 1 Recall of approximately 629 units of the CORTRAK*2 Ental Access System. This feeding tube-placement device has been linked to numerous deaths and injuries.
Cortrak 2 eternal access system The recalled devices were distributed between April 1 in 2016 and January 1, 2022. The devices are employed by healthcare professionals to insert feeding tubes into patients' stomachs or intestines.
Incorrect placement of nasogastric as well as Nasoenteric tubes has been the cause of the deaths of 23 and injuries to 60 since the year 2015.
The recall is used to change the label on the device in order to instruct users to verify that the tube is properly placed prior to delivering food.
Avanos Medical feeding tube "Adverse events reported included respiratory failure as well as pneumothorax (collapsed lung) perforation (a hole in the lung's wall or esophagus or bowel), pneumonia (a lung infection), and the pleural effusion (excess fluid that is leaking from the lung's space and 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 [email protected]. Cortrak 2 eternal access system https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 Cortrak 2 eternal access system
My Website: https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54
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