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Avanos Medical faces Class I recalls due to the connection of the feeding tube system up to 23 deaths.

The FDA has given its most severe warning in relation to the recall of Avanos Medical's enteral feeding tube positioning system.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. This system lets you observe the real-time positioning of a medical feed tube within the stomach of a patient.

Despite this task the system has been linked to dozens of patient injuries, prompting Avanos to issue an recall earlier in the year of all Cortrak*2 devices between January 2021 and January 2022--totaling more than 630 devices that were released between April 2016 and the beginning of this year.

The safety incident isn't a recall in the literal sense of the word: Avanos is not asking health professionals to return the devices back to the manufacturer, instead, they want to make sure they're using them in a safe manner.

Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or trachea. This could result in serious injury, or even death. Avanos has reported more than 60 injury cases since 2015, according to FDA. Cortrak 2 eternal access system All of this was due to FDA's Cortrak*2 system, which guides the placement of feeding tubes.

Avanos Medical feeding tube https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical There are several injuries reported such as respiratory failure, lung infection and collapsed lung.

The FDA issued a march 21 field correction notice that the Georgia-based firm reminded users to verify the positioning of nasogastric tubes as well as Nasoenteric pipes in accordance with institutional guidelines. Avanos has requested that users attach a safety notice to their operating manual and to confirm they've received the new.

https://www.simmonsandfletcher.com/blog/injuries-incorrect-feeding-tube-placement/ Avanos announced that it will soon issue updated labeling for its device. It will also include instructions to indicate the location of a tube in accordance to the guidelines of their facility.

This is the FDA’s second caution in relation to enteral-feeding tubes. In February, the agency put out an safety communication to inform healthcare professionals and parents of the possibility of strangulation when children use feeding tubes.

The notice was issued as a result of two deaths reported in 2021. Each incident was a result of a tubing system that was accidentally wrapped around the neck of a newborn younger than 2 when the child was not being observed by staff at the hospital.

Avanos Medical "While the FDA believes that death or serious injury due to strangulation caused by tubing for feeding through the enteral system for children is extremely rare Healthcare professionals and caregivers should be aware that such events can and do occur," the agency said in its notice and suggested that similar incidents may not have been reported to the FDA.


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