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Avanos is in danger of FDA Class I recall following 23 deaths related to the device
Avanos Medical Cortrak*2 Enal Access System is designed for trained health professionals to place medical feeding tubes in the stomach or small bowels of patients who require nutritional support. Cortrak 2 eternal access system In 2015, however, 23 people have passed away due to complications related to the feeding tube.

Many reports have revealed that patients have suffered trauma or even died when their nasogastric tubes or nasoenteric ones were misplaced. It's despite the fact that the device was designed to aid in their placement.

feeding tube placement This recall will modify the labels of the device, such as the instructions for usage and intended uses. Users are instructed to verify that the tube is set in accordance with the guidelines of their institution before applying it to provide nutrition.

Patients may suffer serious injuries or even death in the event that a nasogastric tube, or nasoenteric tube is not correctly placed.

The recall notice from Avanos Medical declared that there were 60 injuries and 23 deaths linked to the misplacement or removal of nasogastric feed tubes during using the CORTRAK*2 enteral Access System. Avanos Medical This occurred since 2015. Pneumothorax (collapsed lung), pneumothorax ("collapsed lung"), perforation ("hole in the wall, or bowel of the lung), pneumonia (a bacteria-infected infection of the lungs) and the pleural fluid (excess fluid between the lungs).

Avanos Medical issued on March 21, 2022 a field correction notice to its customers who use these devices between January 20,21 and January 20,22. The notice contained the following guidelines:

Check the positioning of nasogastric and Nasoenteric tubes in accordance with institutional guidelines.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ Attach the correction notice from the field that explains the problem to the operator’s manual.
Avanos Mediacal Cortrak 2 Avanos Med will ask you to return the acknowledgment sheet that was included in the email notice.
Website: https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas
     
 
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