The Avanos MedicalCortrak*2 Enteral Access System is designed to assist trained health care personnel place medical feeding tubes in the stomach or small bowel of patients who need to get nutrition via the tube. There are 23 deaths linked to the feeding tube since the year 2015. Cortrak 2 eternal access system Avanos Medical feeding tube Patients have been killed and injured as a result of inadvertently placed nasogastric/naso devices. Avanos Medical This recall is being used to make updates to the device's labeling, including the instructions for use as well as intended uses. The users are advised to confirm that the tube has been placed in accordance with the guidelines of their institution before using it to deliver nutrition. The patient's vocal cords, lungs, and the trachea can be damaged if the nasogastric/nasoenteric tube was installed incorrectly. https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices This can result in grave injury or even death. According to the Avanos Medical recall announcement There were 60 injuries and 23 deaths of patients due to misplacement of nasogastric feeding tubes while making use of the CORTRAK* 2 Enteral Access System, since 2015. Pneumothorax (collapsed lung) or pneumothorax (collapsed lung) perforation (hole in the wall or the bowels of the lung) and pneumonia (a bacterial infection in the lungs) and the pleural fluid (excess fluid between the lungs. Avanos Medical issued a correction notice to customers who had used these devices between January 2021 through January 2022 on March 21, 2022. Cortrak 2 eternal access system The following instructions were contained in the notice: Confirm the placement of nasogastric and nasoent according to the institutional guidelines Attach the corrective notice in the field in the operator's manual. Avanos will need to acknowledge receipt of the email message. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
Cortrak 2 eternal access system|Avanos Medical feeding tube|Avanos Medical|https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices|Cortrak 2 eternal access system|https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns