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Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths in the last year.

After seven years' of failure for Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placing System has been recalled by the FDA has issued the most severe recall orders.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. It provides a continuous stream of medical tube feeding being placed into patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and the elimination of any complications.

Avanos started the recall earlier this year of all Cortrak*2 equipment that was used between January 2021 to Jan 2022. There were nearly 630 devices initially distributed between April 2016 to the beginning.

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The safety incident isn't a recall, in the literal sense: Avanos is not asking healthcare professionals to send the devices back to the manufacturer, instead, they want to make sure they're using the devices correctly.

Avanos Medical feeding tube A feeding tube that isn't properly inserted could result in serious injuries or even death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all of which were related to FDA's usage of the Cortrak*2 system to guide the installation of a feeding tube.

There are several injuries that have been reported like respiratory failure, collapsed lung and lung infections.

According to FDA the Georgia-based firm advised users in the March 21 Field Correction Notification to "confirm the use of nasogastric tubes and Nasoenteric tubes in accordance with the policies of the institution". They've also been asked to add the safety note to the operating manual of the system and verify with Avanos that they have received the update.

Avanos has stated that it will soon issue new labeling for its device. This labeling will include the direction for mapping the tube's location, in accordance with the policies of their facility.

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The FDA has issued a second warning in relation to tube feeding through the stomach. In February, the FDA issued an safety alert to parents and healthcare professionals about the danger of strangulation for children who use feeding tubes.

Avanos Mediacal Cortrak 2 Following two reports of deaths that occurred in 2021, the notification was issued. In each instance, a tubing system was found to have inadvertently wrapped around the neck of a patient under the age of two when they weren't directly watched by the medical staff or caregivers.

"While the FDA believes strangulation by enteral feeding tube tubing in children is unlikely to result in fatal injury or death, caregivers and healthcare providers must be aware of the potential risk," the FDA stated in its notice. Cortrak 2 eternal access system It also suggested that similar cases may not have been reported to the FDA.

Cortrak 2 eternal access system Avanos Medical
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