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Avanos Medical, FDA and the FDA have issued an Class 1 Recall for 629 units of CORTRAK*2's Ental Access System. This feeding tube placement device has been associated with many deaths and injuries.
https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ The devices for recall were made available between April 1 in 2016 until January 1, 2022. They're used to assist healthcare professionals to insert feeding tubes into the stomach or the intestines in patients.
Avanos Medical feeding tube Since 2015, there's been 20 deaths and 60 injuries reported for nasogastric or nasal tubes that were placed in a wrong way.
The recall is used to change the label on the device in order to inform users to ensure that the tube is correctly placed prior to feeding.
"Adverse instances reported were respiratory failure and pneumothorax (collapsed lung) and perforation (a hole in the lung's wall, esophagus, or bowel) or pneumonia (a lung infection) and an effusion of the pleura (excess fluid that is leaking from the space between the lungs and the chest cavity)," according to the FDA.
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]. Avanos Medical Cortrak 2 eternal access system
My Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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