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Avanos Medical faces Class I recalls on its feeding tube system associated with 23 deaths since 2015

After seven years' of failure for Avanos Medical’s Enteral Feeding Tube Placement System, the FDA has designated the most severe class for recalls.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver, and a screen. It can be utilized in conjunction with the system to provide a live feed that illustrates the process of inserting a feeding tube in the stomach of an individual. Avanos Medical This procedure is carried out in the hope of increasing precision and reducing the risk of complications.

Avanos was not satisfied with the mission and launched a recall of all Cortrak*2 units between January 2021 & January 2022. The recall affected more than 630 units which were distributed between April 2016 & the beginning this year.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview The incident that caused the safety issue isn't a recall in the strictest sense. Avanos does not ask healthcare providers to have the device returned to the maker. It's merely to ensure that they're using the device in a safe manner.

Avanos Medical https://goalz.online/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015-fiercebiotech/ A feeding tube that is not properly inserted could cause serious injury or even death. Avanos reported more than 23 deaths and 60 injuries in 2015, the FDA stated. All of these were connected to FDA's Cortrak*2 system that is used to insert the feeding tube.

The injuries reported include respiratory failure as well as lung collapse, lung infection as well as pleural effusion. holes in the walls of the lungs as well as the esophagus and bowel.

According to FDA the Georgia-based firm issued users a March 21 field safety notice to "confirm the placement of nasogastric/nasoenteric tubs to the institution's policies". The company also asked users to attach the safety warning to the operating manual of the system and confirm with Avanos that they have received the latest version of the notice.

Avanos indicated that it will soon issue updated labels for the device. feeding tube placement They will also include the instructions for where to place the tube in accordance with their policies.

This is the second caution the FDA has issued this year with regard to feeding tubes for the enteral system. In February, the FDA issued the safety advisory to healthcare providers and parents regarding the dangers of strangulation among children who use feeding tubes.

The notice came after two reports of death in 2021. Avanos Medical feeding tube In each case, a tubing system was discovered to have inadvertently wrapped around the neck of a patient under the age of two when they weren't directly watched by the medical staff or caregivers.

"While the FDA considers strangulation caused by enteral feed set tubing in children is rare, healthcare providers should be aware of such incidents," the agency stated in the announcement. This indicates that similar incidents could not have been reported to the FDA.


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