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Avanos is Recalled by FDA Class I following 23 deaths related to the device
The Avanos Medical Cortrak*2 Ental Access System was created to aid trained health care professionals in placing medical feeding tubes into patients' small intestines or stomachs. However, since 2015, there have been 23 deaths related to the feeding tube.

Patients have died and injuries as a result of incorrect placement of nasoenteric/nasogastric tube devices.

feeding tube placement Avanos Medical This recall is used to update the device's labeling, which includes the directions for use and the intended use. These updates require users to confirm the placement of the tube according to their institution's protocols before using the tube to provide nutrients.

The patient's vocal cords, lungs and the trachea can be damaged if the nasogastric/nasoenteric tube was inserted incorrectly. This can result in serious injury or even death.

Avanos Medical feeding tube Avanos Medical's recall communications declared that there had been sixty accidents, 23 deaths and 58 patients injured by the misplacement of Nasogastric tubes. The CORTRAK*2 access system has been in operation since 2015. Pneumothorax (collapsed lung) also known as pneumothorax ("collapsed lung") perforation ("hole in the wall, or the bowel of the lung) as well as pneumonia (a bacterial infection in the lungs) and the pleural liquid (excess fluid that is accumulated between the lungs).

Avanos Mediacal Cortrak 2 On March 21 2022, Avanos Medical issued a field correction notice to customers who had used the devices between January 2021 and January 2022. The notice contained the following instructions:

Verify the placement of the nasogastric, nasal and other tubes in line with institutional guidelines.
Add the notice of correction for field about the issue to the operator's manual.
Avanos Mediacal Cortrak 2 Avanos Medical will send the acknowledgment form that was included in the email notice.
Website: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
     
 
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