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Avanos Recalls FDA Class II Following 23 Deaths Involved with the device
Avanos Medical Cortrak*2 Enal Access System was designed to allow trained health professionals to place medical feeding tubes in the stomachs or small bowels of patients that require nutritional assistance. Cortrak 2 eternal access system There were 23 deaths attributed to the feeding tube since 2015.

There have been numerous instances of patients suffering injuries and even deaths due to misalignment or misplacement of nasogastric, or nasal, or nasoenteric tube. Avanos Medical feeding tube They are utilized to aid in their placement.

This recall is utilized to create updates to the device's labeling, including the instructions for use as well as intended uses. These changes require that users verify tube placement in accordance with the protocols of their institution prior to using the tube to distribute nutrients.

Avanos Medical https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Patients may suffer serious injury or even death due to incorrectly placed nasogastric and nasoenteric tubes.

According to the Avanos Medical recall notice, there were 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System, since 2015. The adverse events identified were respiratory failure, pneumothorax, collapsed lung perforation (a opening in the esophagus's wall or lung), pneumonia (a lung infection), pleural effusion, excessive fluid between the lungs, and the chest cavity, as well as pneumothorax.

Avanos Medical issued a correction notice to customers who used these devices in the period January 2021 through January 2022 on March 21, 2022. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview The notice contained the following guidelines:

Verify the placement of nasogastric/nasoenteric in accordance with institutional policies
Attach the corrected field notice regarding the issue to the operator's manual.
Avanos Health Medical requires to return the acknowledgement form enclosed with the emailed notification Avanos Medical Avanos Medical feeding tube Avanos Medical
Homepage: https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
     
 
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