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Avanos Medical faces Class I recall for feeding tube system implicated in 23 deaths in 2015

After seven years of bad luck with Avanos Medical's insertal feeding tube placement device for children The FDA has issued its most serious warning regarding the recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with the capability of displaying a screen monitor. In combination this system allows you to view the live installation of a medical feed tube into a patient's stomach.

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Cortrak 2 eternal access system Avanos launched a recall earlier in the year for all Cortrak*2 devices which were in use between January 2021 to January 2022. Cortrak 2 eternal access system The total number of affected devices was 630. devices, which was distributed for the first time between April 2016 until the beginning of 2016.

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The safety incident doesn't count as a recall in any strict sense: Avanos isn't asking healthcare providers for the device to be returned back to the manufacturer. Avanos Mediacal Cortrak 2 It's just to make sure that they're using the device in a safe manner.

A feeding tube that isn't properly inserted could result in serious injury or death. In actual fact, Avanos has received reports of deaths of 23 and 60 injuries since 2015 the FDA said that all of them were related to the use of the Cortrak*2 system to guide the placement of the feeding tube.

feeding tube placement The most common injuries are respiratory failure and collapsed lung, lung infection as well as pleural effusion. holes in the lung's walls as well as the esophagus and bowel.

According to FDA Avanos, a Georgia-based business issued a March 21 field correction note reminding users to confirm the position of nasogastric tubes as well as nasoenteric tubs according to institutional guidelines. feeding tube placement They've also been asked to attach the safety warning to the operating manual of the system and to confirm with Avanos that they have received the latest version of the notice.

Avanos announced that they would soon issue an updated labeling for the device. It will include the instructions for placing a tube according to their guidelines.

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This is the second caution that the FDA has issued this year with regard to feeding tubes for the enteral system. In February, the FDA issued a safety announcement informing healthcare professionals and parents of the possibility of strangulation when children use feeding tubes.

Two deaths in 2021 were disclosed to the notice. The tubing system was not being controlled by caregivers or staff was wrapped around necks and necks of children less than two years old.

"While the FDA believes that strangulation from tubes for feeding tubes in the gastrointestinal tract of children is not likely to cause death or serious injury caregivers and healthcare professionals must be aware of the potential risk," the FDA stated in the notice. It also noted that other similar cases might not have been reported to the FDA.


Read More: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview