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Avanos Medical faces Class I recall for feeding tube system that has been linked to 23 deaths since 2015

After seven years during which Avanos Medical's tube placement device was plagued by unlucky luck and a lack of trust, the FDA has issued its most severe directive to recall the product.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. It provides a continuous feed of medical feeding tubes being placed in patients' stomachs or small bowels. Cortrak 2 eternal access system Cortrak 2 eternal access system This allows for improvement of tip placement accuracy and the reduction of complications.

Avanos Medical feeding tube Avanos launched a recall earlier in the year for all Cortrak*2 devices which were in use between January 2021 to January 2022. It was nearly 630 devices, which was distributed for the first time between April 2016 and the beginning of 2016.

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The safety incident isn't a recall, in the strict sense: Avanos is not asking health professionals to return the devices back to the manufacturer but to ensure that they're using the devices correctly.

If a feeding tube is placed incorrectly, it can damage the vocal cords, lungs or the trachea and cause severe injury or death. feeding tube placement Avanos has reported the deaths of 23 people and 60 injuries cases since 2015 according to the FDA. This is all because of the FDA's Cortrak*2 system, which guides placing feeding tubes.

Numerous injuries have been reported such as respiratory failure (collapsed lung) lung infection, holes inside the walls and esophagus.

The FDA has reminded patients that they need to confirm the placement of nasogastric or nasoenteric tube in accordance with their institution guidelines in the March 21 field correction notification. They're also required to attach the safety notice to the system's operating manual and to confirm with Avanos that they received the latest version of the notice.

Avanos announced that they would soon issue updated labeling to the device. It will include the directions to put the tube in accordance with their guidelines.

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This is the FDA's second warning regarding tube feeding through the stomach. In February, the FDA published an safety communications warning parents and health professionals of the dangers of strangulation as a result of the use of feeding tubes by children.

The announcement followed two instances of deaths in 2021. A tubing system that was not being closely monitored by the staff or caregivers was wrapped around necks and necks of children under two years old.

"While the FDA believes strangulation by enteral feeding tube tubing in children is unlikely to result in death or serious injury Healthcare providers and caregivers should be aware of this possibility," the FDA stated in the notice. It also noted that similar incidents could not have been reported yet to the FDA.


Here's my website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical