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Avanos Medical Recalls Cortrak*2 Ental Access System
According to the U.S. Food & Drug Administration (FDA), Avanos Medical is recalling the Cortrak*2 Enteral Access System due to the incorrect placement of nasogastric and nasoenteric tubes has resulted in injury and death of patients. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns The recall covers 629 devices in use throughout the United States.

Avanos Mediacal Cortrak 2 Avanos has promoted the Cortrak*2 Enteral Access System due to its interactive display of a patient's stomach or small bowel, to aid in the proper positioning of a medical feed tube. Patients could suffer damage to their vocal chords, lungs or the trachea, if a tube is not correctly placed. Avanos Medical has reported that there have been more than 60 injuries and 23 deaths caused by misplacement of nasogastric feeding tubes using CORTRAK*2's Ental Access System. There have been numerous injuries, including pneumothorax, respiratory failure or collapsed lung, perforation (a hole in the wall of your lungs or the bowel) pneumonia, and the pleural effusion. This is excess fluid between your lungs and the chest cavity.

https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its Avanos Medical described a plan for users to get updated labeling to confirm proper use of the nasogastric tube and nasoenteric pipe prior to use.

The Avanos warning was the second FDA warning in 2022 regarding feeding tubes for the enteral system. https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/ The FDA issued a caution to parents and healthcare providers concerning the risk of strangulation in the event that feeding tubes are used by children. Two cases of strangulation by a child occurred in 2021. This was due to tubes that were placed around the neck of the patient.

FDA Recalls Avanos Medical Device

Possible Risks of Enteral Feeding Delivery sets

Cortrak* 2 Enteral Access System Product Details

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