Notes

Avanos Medical faces a Class I recall for its the feeding tube system that was linked to 23 deaths that occurred in 2015

After seven years of unlucky luck for Avanos Medical's enteral feeding tube placement system The FDA has issued its most severe designation for a recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with an LCD monitor. The system can be utilized in conjunction with the system to provide a live feed that shows the procedure of inserting a medical feed tube into the stomach of an individual. This procedure is carried out to improve the accuracy of the procedure and decreasing complications.

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

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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 company that made it. It's merely to ensure that they're using the device in a safe manner.

If a tube for feeding is placed incorrectly, it can damage the vocal cords, lungs or trachea and cause severe injury or death. Avanos Medical feeding tube In actual fact, Avanos has received reports of more than 60 injuries since the year 2015, the FDA said, all of which were linked to the the Cortrak*2 system to aid in the placement of a feeding tube.

Avanos Medical Some of the injuries reported include respiratory failure, lung collapse, lung infections, and holes in the walls of the esophagus and lungs.

According to FDA, in its March 21 field correction announcement, the Georgia-based company advised users to "confirm the installation of nasogastric/nasoenteric pipe in accordance with the institution's policies". Avanos asked users to include the safety notice in the system's operation manual and then confirm that they have notified Avanos that the change was accepted.

https://washingtonindependent.com/deadliest-fda-recalls-2022-misplaced-feeding-tubes-leading/ Avanos has indicated that it will soon issue a new label for its device. The labeling will be able to include directions to determine a tube's location in accordance their policies for their facilities.

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This is the second FDA warning of the year for the use of enteral feeding tubes. https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events In February, the FDA issued an safety communication warning parents and health professionals of the possibility of strangulation resulting from the use of feeding tubes for children.

In the wake of two deaths that occurred in 2021, the notification was issued. Each time the notice was followed by two deaths in 2021.

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


Read More: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/