Notes

Avanos Recalls FDA Class II Following 23 Deaths Involved with the device
Avanos Medical Cortrak 2 Entry Access System was designed to aid health care personnel in inserting medical feed tubes in the small bowel or stomach of patients who require nutrition. feeding tube placement There were 23 deaths attributed to the feeding tube since the year 2015.

Patients have died and injuries due to incorrect placement of nasoenteric/nasogastric tube devices.

This recall is used to modify the device's labels, including the instructions for usage and the intended usage. The updates instruct users to confirm tube placement in accordance with the guidelines of their institution before using the tube for delivering nutritional supplements.

The patient's vocal cords, lungs, and trachea could be damaged when the nasogastric/nasoenteric tube is installed improperly. Avanos Mediacal Cortrak 2 Avanos Medical This could result in grave injury or even death.

Avanos Medical recalls that there was a total of sixty injuries and 23 deaths from misplacement in nasogastric tube placements in the last year. Avanos Medical Pneumothorax, respiratory failure, perforation (a hole, or hole in the stomach or wall) and pneumonia were all mentioned.

Avanos Medical sent a field correction notice on the 21st of March 2022 to customers who utilized the devices between January 2021 and January 2022. Avanos Mediacal Cortrak 2 The notice contained the following guidelines:

Confirm placements of nasogastric/nasoenteric tubes in accordance with institutional policies
Attach the corrective notice in the field to the operator's handbook.
Avanos Med will require you to return the acknowledgment sheet included with your emailed notice.
My Website: https://www.transtats.bts.gov/exit.asp?url=https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/