Notes

Avanos faces FDA Class I recall following 23 deaths linked to the device
Avanos Medical Cortrak 2 Entry Access Systems is designed to aid trained health care personnel in inserting medical feeding tubes into the small bowel or stomach of patients who are requiring nutrition. The tube that feeds patients has been implicated in 23 deaths in the last year.

There have been numerous reports of injuries and patient deaths that have occurred when nasogastric tubes were misplaced while this device is utilized to aid in their placement.

This recall is being used to update the device's labeling that include the directions on how to use it. These changes require that users confirm the placement of the tube according to their institution's protocols prior to using the tube to deliver nutrients.

Avanos Medical Patients may suffer serious injury or death from incorrectly inserted Nasogastric tubes and nasoenteric ones.

Avanos Mediacal Cortrak 2 Avanos Medical recalls that there has been a total of sixty accidents and 23 deaths due to the incorrect placement of nasogastric tubes from 2015. The adverse events that were reported include respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus or bowel) and pneumonia (a lung infection) and pleural effusion (excess fluid in the lung space and chest cavity).

Avanos Medical feeding tube On the 21st of March, 2022, Avanos Medical issued a field correction notice to its customers who utilized these devices between January 2021 and January 2022. https://app.glosbe.com/profile/7016944997278682355 The following information was included in the notice.

Place nasogastric or nasoenteric tubs in accordance with the institution's policies.
Avanos Mediacal Cortrak 2 Attach the corrected field notice regarding the issue to the operator's manual.
Avanos Health Medical asks to return the acknowledgement form enclosed with the emailed notification
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