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Avanos Medical Cortrak*2 enteral access system was designed to allow health care professionals to place medical feeding tubes into the small intestine or stomach of patients who require nutritional assistance. There have been 23 deaths reported to date as a result of feeding tubes since 2015.
Avanos Medical feeding tube There have been numerous instances of patient injuries and deaths resulting from misalignment or misplacement of nasogastric, or the nasoenteric tubes. Avanos Medical feeding tube These devices are used to assist in the placement of their tubes.
Avanos Medical This recall is used to change the information on the device's label, including the instructions and their intended uses. The users are advised to confirm that the tube is placed in accordance with the guidelines of their institution before applying it to provide nutrition.
Patients may suffer serious injury or even death due to incorrectly placed Nasogastric tubes and nasoenteric ones.
Avanos Medical's recall communications declared that there had been 60 incidents, 23 deaths, and 58 patients hurt by the misplacement of the nasogastric tubes. The CORTRAK*2 access system has been in use since 2015. Affected events include respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the lung's wall or esophagus) as well as pneumonia (a lung infection), and an effusion of the pleura (excess fluid that has accumulated in the space between the lungs and the chest cavity).
On March 21 2022 Avanos Medical issued a field correction notification to its customers who utilized these devices between January 2021 and January 2022. Avanos Mediacal Cortrak 2 https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ The following instructions were contained in the notice:
Install nasogastric tubs or nasoenteric tub in accordance with the institution's policies.
Attach the correct notice in the field regarding the issue to your operator's manual.
Avanos Med will ask that you return the acknowledgement sheet that was included in your email notification.
Homepage: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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