Notes

Avanos Medical faces a Class I recall over feeding tube system connected to 23 deaths that occurred in 2015

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

Cortrak*2 Enteral Access System contains an electromagnetic stylet , as well as an external receiver. It can be used in conjunction to provide a live feed that shows the procedure of inserting a medical feed tube into the stomach of a patient. This is done to improve accuracy and reducing complications.

Cortrak 2 eternal access system Cortrak 2 eternal access system Avanos was not happy with the results and announced a recall of all Cortrak*2 units between January 2021 and January 2022. feeding tube placement The recall covered approximately 630 units which were distributed between April 2016 & the beginning this 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 manufacturer. It's just to make sure that they're properly using them.

A feeding tube that is not properly placed can cause damage to the vocal cords, lungs, or the trachea. This could result in 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 placement of the feeding tube.

There are many injuries which have been reported like respiratory failure, collapsed lung, and lung infection.

According to FDA, in its March 21 field correct announcement, the Georgia-based company reminded users to "confirm placement nasogastric/nasoenteric pipes according to the policies of the institution". Avanos requested that users add the safety announcement to the system's operation manual and then confirm with Avanos that the update was accepted.

feeding tube placement Avanos said it would soon issue updated labels for the device. They will contain instructions on where to put the tube, in accordance with their guidelines.

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This is the second FDA warning on tube feeding into the gastrointestinal tract this year. In February, the FDA issued a safety message informing parents and healthcare providers about the possibility of strangulation of children using feeding tubes.

Following two death reports in 2021, this notice was issued. The tubing system was not being monitored by staff or caregivers wrapped around the necks and necks of children less than two years of age.

"While the FDA believes that serious injury or death from strangulation with tubing for feeding through the enteral system in children is rare healthcare professionals and their caregivers must be aware that such events are possible and can happen," the agency said in the notice and suggested that similar incidents may not have been reported to the FDA.


My Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical