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Avanos Medical faces Class I recall because of feeding tube system connection up to 23 deaths.

After seven years of bad luck for the Avanos Medical enteral feeding tube placement device Avanos Medical's enteral feeding tube placement system, the FDA has issued its most severe designation for recalls of the product.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as an LCD monitor. The system, when combined, provides live video of the medical feeding tube being placed in a patient's stomach.

Avanos issued a recall earlier in the year for all Cortrak*2 devices that were used between January 2021 to January 2022. The total number of affected devices was 630. devices. They were distributed for the first time between April 2016 to the beginning of 2016.

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The incident that caused the safety issue isn't an recall in the strictest sense. Avanos does not ask healthcare providers for the device to be returned to the manufacturer. It's merely to ensure that they're using it correctly.

A feeding tube that is not correctly placed can result in severe injuries or even death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, since 2015, all of which were related to FDA's use of the Cortrak*2 system for guiding the placement of the feeding tube.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm The most common injuries include respiratory failure and collapsed lung infected lung, as well as holes in the walls of the lungs and esophagus.

The FDA reminded users that they must confirm that they have placed a nasogastric tube in accordance with their institution policies in its March 21 field correction notice. Avanos has also asked users to add the note on safety to the operating guideline of the device and verify that they have received the latest update.

Avanos announced that they would soon issue new labeling on the device. It will include the direction to place a tube according to their guidelines.

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The FDA has issued a second caution regarding the use of an enteral tube for feeding use. In February, the FDA released a safety announcement informing healthcare professionals and parents about the danger of strangulation for children using feeding tubes.

Two deaths in 2021 were reported to the notice. Each time, the notice was followed by two deaths in 2021.

"The FDA believes that death and serious injury due to strangulation caused by tubing used for enteral feeding for children is extremely rare. But, healthcare professionals, and caregivers, should be aware that such events may and do happen," the FDA said in the announcement. The FDA said that similar cases could not yet be reported to the FDA.

Avanos Mediacal Cortrak 2
Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement