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The Avanos MedicalCortrak*2 Enteral Access System is designed to help medical professionals who are trained to insert medical feeding tubes into the stomach or small bowel of patients who have to receive nutrition via the tube. There are 23 deaths linked to the feeding tube since the year 2015.
Avanos Mediacal Cortrak 2 There have been substantive reports of injuries and patient deaths that have occurred when nasogastric tubes were misplaced while this device is used to assist in their place.
The recall was used to create revisions to the device’s labels and instructions for use and uses. These changes require that users verify tube placement as per the guidelines of their institution prior to using the tube to distribute nutrients.
Cortrak 2 eternal access system Patients can suffer serious injuries or even die in the event that a nasogastric tube, or nasoenteric tub has been incorrectly installed.
Avanos Medical feeding tube The recall notice from Avanos Medical declared that there were more than 23 deaths and 60 injuries caused by the misplacement, or removal of nasogastric feed tube during use of the CORTRAK*2 Enteral Access System. This occurred in the year 2015. https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ The adverse events noted were respiratory failure, pneumothorax or collapsed lung perforation (a hole through the wall of your esophagus or lung) as well as pneumonia (a lung infection) as well as pleural effusion. excess fluid in the lungs and the chest cavity, and pneumothorax.
On the 21st of March, 2022, Avanos Medical issued a field correction notification to its customers who utilized these devices between January 2021 to January 2022. The following information was included in the notice.
Cortrak 2 eternal access system Install nasogastric tubs or nasoenteric tub according to institution policies.
Attach the appropriate field correction notice to the operator's guide.
Avanos Medical will provide the acknowledgement form included in the email notice.
Homepage: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
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