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Avanos Medical Cortrak*2 Enteral Access System is designed to assist medical professionals who are trained to insert medical feeding tubes into the stomach or small bowel of patients who have to be fed through the tube. There have been 23 deaths reported to date as a result of feeding tubes since 2015.
There have been substantive reports of injuries and deaths that have occurred when nasogastric tubes are misplaced after the device is used to aid in their positioning.
This recall will be used to modify the labeling of the device as well as the instruction and the intended use. The new instructions advise users to verify the tube's placement according to the protocols of their institution prior to using the tube to deliver nutrition.
The vocal cords, lungs, and the trachea can be damaged in the event that the nasogastric/nasoenteric installed in a wrong way. This can result in serious injury or even death.
Avanos Medical's recall notification said that there were more than 23 deaths and 60 injuries caused by the misplacement, or removal of the nasogastric feed tube during using the CORTRAK*2 enteral Access System. Avanos Medical Avanos Medical https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns This occurred since the year 2015. Pneumothorax, respiratory failure, perforation (a hole, in the stomach or wall) and pneumonia were all reported.
https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ Avanos Medical, on March 21, 2022, issued a corrective field notice to its customers who had used the products between January 2021-January 2022. The notice included the following information:
Verify the placement of the nasogastric, nasal and other tubes in line with the policies of the institution.
Include the field correction notice regarding the issue to the operator's manual.
Avanos Medical feeding tube Avanos Health Medical requests that you return the acknowledgment form enclosed with the emailed announcement Avanos Medical
Read More: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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