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Avanos Recalls FDA Class II Following 23 Deaths Associated with the Device
Avanos Medical Cortrak*2 Enal Access System was designed to allow trained health professionals to place medical feeding tubes in the stomach or small bowels of patients who require nutritional support. The feeding tube has been associated with 23 deaths since the year 2015.

Avanos Medical feeding tube Patients have died and injuries as a result of misplacement of nasoenteric/nasogastric tube placement devices.

This recall is used to make updates to the device's labeling, which includes the instructions for use as well as the intended use. https://escatter11.fullerton.edu/nfs/show_user.php?userid=2740932 The updates will require users to confirm the placement of the tube according to their institution's protocols prior to using the tube to provide nutrients.

Incorrectly inserting a Nasogastric or Nasoenteric tube can cause damage to the vocal chords, lungs or the trachea. This can lead to serious injury and even death.

Avanos Medical recalls that there have been sixty injuries and 23 deaths from misplacement in nasogastric tube placements since 2015. https://dohabb.com/index.php?page=user&action=pub_profile&id=1483571 The adverse events that were reported included respiratory failure, pneumothorax or collapsed lung perforation (a hole in the wall of your esophagus or lung) as well as pneumonia (a lung infection), pleural effusion, excessive fluid between the lungs and chest cavity, and pneumothorax.

Avanos Medical issued a correction notice to those who purchased these devices between January 2021 to January 2022 on the 21st of March 2022. The notice included the following instructions:

Use nasogastric or Nasoenteric tubs according to the policies of the institution.
Attach the correction notice from the field describing the issue to the operator's manual.
Avanos Medical Avanos will be required to acknowledge the receipt of the email notification. Cortrak 2 eternal access system
Website: https://dohabb.com/index.php?page=user&action=pub_profile&id=1483571
     
 
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