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Avanos Medical Cortrak*2 Ental Access System is designed for qualified health professionals to put medically-approved feeding tubes into the stomach or small bowels of those who require nutritional assistance. Avanos Medical feeding tube There have been 23 deaths reported to date due to the feeding tubes since the year 2015.
Avanos Mediacal Cortrak 2 There have been substantive reports of injuries and deaths that have occurred when nasogastric tubes are misplaced after this device is utilized to help with their placement.
This recall is used to modify the information on the device's label as well as the instruction and the intended use. It is recommended that users verify that the tube is set according to the protocols of their institute prior to applying it to provide nutrition.
If a nasogastric or nasoenteric tube is inserted incorrectly the patient could suffer damage to vocal cords, lungs or trachea, all that could lead to severe injuries or even death.
Avanos Medical recalls that there has been a total of 60 injuries and 23 deaths from the incorrect placement of nasogastric tubes in the last year. Respiratory failure, pneumothorax, perforation (a hole, in the stomach wall) and pneumonia were all reported.
Avanos Mediacal Cortrak 2 Avanos Medical issued a correction notice to those who purchased these devices between January 2021 to January 2022 on March 21, 2022. Avanos Mediacal Cortrak 2 The notice contained the following guidelines:
Confirm the placement of Nasogastric tubes as well as nasoenteric tubes as per the policies of the institution.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Attach the relevant field correction notice to the operator’s guide.
Avanos Med will require that you return the acknowledgment sheet included with your emailed notice. feeding tube placement
Homepage: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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