Notes

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

After seven years of failures in Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placing System has been recalled by the FDA has issued the most severe recall order.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver as well as an LCD monitor. It provides a continuous feed of medical feeding tubes being placed into patients' stomachs or small bowels. This allows for the advancement of the precision of tip placement and the reduction of complications.

Avanos was not pleased with the results and announced a recall of all Cortrak*2 units between January 2021 & January 2022. The recall covered nearly 630 devices that were distributed between April 2016 and the start of this year.

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The incident that caused the safety issue isn't a recall in the strictest sense. feeding tube placement Avanos isn't asking healthcare providers for the device to be returned back to the company that made it. It's simply to make sure that they're using the device in a safe manner.

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

Some of the injuries reported include respiratory failure and lung collapse as well as lung infections. holes in the walls of the esophagus and lungs.

Cortrak 2 eternal access system In its March 21 field correction announcement, the Georgia-based firm advised users to "confirm the placement of nasogastric as well as Nasoenteric tubes as per guidelines of the institution" as per the FDA. Avanos is also asking them to attach the safety note to the operating manual of the device and to confirm that they have received the updated.

Avanos announced that it will soon release a new labeling guidelines for its product. This will include directions to indicate the location of the tube in line to the policies of their facility.

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The FDA has issued a second caution regarding the use of an enteral tube for feeding use. In February, FDA published a safety alert to healthcare providers and parents about the potential for strangulation in children who use feeding tubes.

The announcement came in the wake of two reports of deaths in 2021. In both cases the tubing system was accidentally tied around the neck of a child when they weren't being closely monitored by caregivers or hospital staff.

"While the FDA believes that serious injury or death due to strangulation caused by tubing for feeding through the enteral system for children is extremely rare healthcare professionals and their caregivers must be aware of the fact that these incidents are possible and can happen," the agency said in its notice warning that similar incidents may not have been reported to the FDA.

Avanos Medical feeding tube
Read More: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system