Notes

Avanos Recalls FDA Class II Following 23 Deaths Involved with the Device
Avanos Medical Cortrak*2 Ental Access System was designed to aid trained health care personnel place medical feeding tubes in the small bowel or stomach of patients who require to get nutrition via the tube. Avanos Medical There were 23 deaths attributed to the feeding tube in 2015.

Avanos Medical Numerous reports have indicated that patients suffered trauma or even died when their nasogastric and nasoenteric tubes were not properly placed. This is despite the fact this device was used to aid in the placement.

The recall will be used to modify the information on the device's label along with the directions and their intended uses. The updated instructions advise users to confirm the location of the tube in accordance with the guidelines of their institution prior to applying them to deliver food.

Incorrectly inserting a Nasogastric or Nasoenteric tube may result in damage to the vocal cords, lungs, or trachea. This could result in grave injury and possibly death.

Avanos Medical's recall notification declared that there were more than 23 deaths and 60 injuries caused by the misplacement, or removal of the nasogastric feed tube during using the CORTRAK*2 enteral Access System. This occurred from the year 2015. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause There have been several adverse events that occurred, including respiratory failure pneumothorax (collapsed lungs), perforation (a gap or opening in the esophagus's wall or bowel), pneumonia, and pleural effusion (excess liquid in the space between your lungs and the chest cavity).

Avanos Medical, on March 21, 2022, sent an correct field notice to customers who used these products between January 2021-January 2022. Cortrak 2 eternal access system Cortrak 2 eternal access system The notice contained the following instructions:

Check the positioning of the Nasogastric tubes as well as nasoenteric tubes according to institution policies.
Attach the correction notice from the field describing the issue to the operator's manual.
Avanos will need to acknowledge receipt of the email notice.
Website: https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/