Notes

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

After seven years of poor luck with Avanos Medical's insertal feeding tube placement system for children The FDA has issued the most severe warning regarding the recall of this device.

Cortrak 2 eternal access system The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a monitor for display. When they are used together the system provides a live feed of the placement of medical-grade feeding tubes into the stomach of a patient or into their small bowel, with an aim of improving the accuracy of the tube's tip placement and reducing complications.

Avanos announced a recall earlier in the year, affecting all Cortrak*2 units which were in use between January 2021 and January 2022. It was nearly 630 devices. They were distributed for the first time between April 2016 until the beginning of the year.

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The safety event is not a reason to issue an recall. https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos has asked healthcare providers not to send the devices back at the manufacturer. But, they would like to make sure that they are using the devices.

A wrongly placed feeding tube can damage vocal cords and lungs. It could also cause severe injury or death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all of them related to FDA's usage of the Cortrak*2 system for guiding the installation of a feeding tube.

Cortrak 2 eternal access system There are many injuries that have been reported, like respiratory failure, collapsed lung, and lung infections.

According to FDA the Georgia-based company reminded users in the March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes as per institutional guidelines". Avanos has asked patients to include a safety note in their operating manuals and verify they have been updated.

Avanos stated that it will shortly issue a revised labeling for its product. https://www.simmonsandfletcher.com/blog/injuries-incorrect-feeding-tube-placement/ It will also include instructions for locating the position of the tube in line to the policies of their facility.

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The FDA has issued a second warning regarding feeding tubes for enteral nutrition. In February, the agency issued an safety message to inform healthcare professionals and parents about the danger of strangulation when children use tubes for feeding.

Two deaths occurred in 2021 and were disclosed in the announcement. Each time, the notice was followed by two deaths in 2021.

Avanos Medical "While the FDA believes death or serious injuries from strangulation caused by enteral food set tubing for children is rare healthcare professionals and caregivers must be aware that such events could and do occur," the FDA noted in the notice.


Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement