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The Avanos MedicalCortrak*2 Enteral Access System was designed to assist trained health care personnel place medical feeding tubes in the stomach or small bowel of patients who require to get nutrition via the tube. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Cortrak 2 eternal access system In 2015, there have been 23 deaths related to feeding tubes.
Avanos Medical There have been numerous reports of injuries and patient deaths after nasoenteric or nasogastric tubes are misplaced after this device is used to assist in their positioning.
This recall is being used to update the device's labeling, which includes the directions for use and the intended use. These updates require users to ensure that the tube is placed as per the guidelines of their institution before using the tube to distribute nutrients.
Patients can suffer severe injury or death from incorrectly inserted the nasogastric or nasoenteric tubes.
In Avanos' recall communication there were 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes when making use of the CORTRAK* 2 Enteral Access System, since 2015. Avanos Medical feeding tube Adverse events reported included respiratory failure and pneumothorax (collapsed lung) and perforation (a hole in the lung's wall, esophagus, or bowel), pneumonia (a lung infection), and the pleural effusion (excess fluid that has accumulated in the lung space and the chest cavity).
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Avanos Medical feeding tube Avanos Medical sent a field correction notice on the 21st of March 2022 to customers who had utilized the devices between January 2021 & January 2022. The following information was included in the notification.
Check the position of the nasogastric, nasoenteric and other tubes in line with institutional guidelines.
Attach the relevant field correction notice to the operator's guide.
Avanos Health Medical requests that you return the acknowledgement form that is included with the emailed notification
Here's my website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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