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The Avanos Medical Cortrak*2 Ental Access System was created to aid trained health professionals with the placement of medical feeding tubes in the small intestines of patients or stomachs. Since 2015, there has been 23 deaths related to feeding tubes.
Numerous reports have shown that patients have sustained trauma or even died when their nasogastric or nasoenteric tubes were not properly placed. Avanos Medical feeding tube This is despite the fact the device was designed to aid in their placement.
Avanos Medical feeding tube This recall is utilized to create updates to the device's labeling, which includes the instructions for use as well as intended uses. Avanos Medical Users are instructed to verify that the tube has been placed in accordance with the specifications of their institute prior to making use of it to deliver food.
Patients can suffer serious injuries or even die in the event that a nasogastric tube, or nasoenteric tube is not correctly installed.
Avanos Medical's recall notice said that there were more than 23 deaths and 60 injuries linked to the misplacement or removal of nasogastric feed tubes in the using the CORTRAK*2 enteral Access System. Avanos Medical feeding tube Cortrak 2 eternal access system Avanos Medical feeding tube This occurred from the year 2015. Adverse events reported included respiratory failure and pneumothorax (collapsed lung) and perforation (a hole in the lung's wall, esophagus, or bowel) and pneumonia (a lung infection), and the pleural effusion (excess fluid that has accumulated in the lung space and chest cavity).
Avanos Medical issued on March 21, 2022, a field correction notice to its customers who were using the devices between January 20,21 and January 20,22. The notice contained the following information:
Verify the placement of nasogastric as well as the nasoenteric tube according to institution policies.
Include the field correction notice regarding the issue to the operator's guide.
Avanos Health Medical asks to return the acknowledgement form with the email notice
Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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