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The Avanos MedicalCortrak*2 Enteral Access System is designed to help healthcare professionals with training to insert medical feeding tubes in the small bowel or stomach of patients who have to get nutrition via the tube. The tube that feeds patients has been implicated in 23 deaths in the last year.
There have been numerous reports of injuries to patients and deaths resulting from misalignment or misplacement of nasogastric, also known as nasoenteric, tubes. These devices are utilized to assist in the placement of their tubes.
Avanos Medical https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause This recall is being used for updates to the device's labeling and instructions for use. Avanos Medical feeding tube These changes require that users verify tube placement according to their institution's protocols prior to using the tube to deliver nutrients.
Cortrak 2 eternal access system Patients may suffer serious injuries or even die when a nasogastric tubing or nasoenteric tub is incorrectly inserted.
In Avanos' recall communication, there were 60 injuries and 23 deaths due to misplacement of nasogastric feeding tubes making use of the CORTRAK* 2 Enteral Access System, since 2015. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Pneumothorax, respiratory failure, perforation (a hole in the stomach wall, or stomach) and pneumonia were all reported.
On the 21st of March, 2022, Avanos Medical issued a field correction notice to customers who had used the devices between January 2021 and January 2022. These instructions were included in the notice:
Check the positioning of the Nasogastric tubes as well as nasoenteric tubes as per the policies of the institution.
Attach the updated notice in the field regarding the issue to your operator's manual.
Avanos Medical will provide the acknowledgment form that was included in the notice emailed to you.
Website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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