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The Avanos Medical Cortrak*2 access system is designed to allow trained health professionals to place medical feeding tubes in the stomach or small intestine of patients that require nutritional assistance. Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system There were 23 deaths attributed to the feeding tube in the year 2015.
There have been numerous instances of patients suffering injuries and even deaths resulting from misalignment or misplacement of nasogastric or nasoenteric, tubes. These devices are employed to aid in their placement.
This recall will be used to change the information on the device's label, including the instructions and their intended uses. feeding tube placement The updates tell users to confirm the location of the tube in accordance with their institution’s protocols before applying them to deliver food.
Patients can suffer severe injury or even death due to incorrectly placed the nasogastric or nasoenteric tubes.
Avanos Medical's recall announcements stated that there have been sixty injuries, 23 deaths, and 58 patients injured by the misplacement of Nasogastric tubes. The CORTRAK*2 access system has been in operation since 2015. Avanos Mediacal Cortrak 2 Adverse events reported included respiratory failure pneumothorax (collapsed lung), perforation (a hole in the lung's wall, esophagus, or bowel) as well as pneumonia (a lung infection), and an effusion of the pleura (excess fluid that has accumulated in the lung space and the chest cavity).
On the 21st of March 2022, Avanos Medical issued a field correction notice to its customers who used these devices between January 2021 and January 2022. These instructions were included in the notification:
Verify the placement of nasogastric as well as nasoenteric tubes according to institutional policies.
Avanos Medical Attach the updated field notice regarding the issue to the operator's manual.
Avanos will need to acknowledge receipt of the email notice.
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