Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have caused 23 deaths in the last year.

After seven years of bad luck for Avanos Medical's feed tube placement system The FDA has given its most severe designation for a recall of the device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as an LCD monitor. Avanos Medical feeding tube feeding tube placement The system, when combined will provide live footage of the medical tube being placed in a patient's stomach.

Despite this mission, it has been implicated in dozens of patient injuries, leading Avanos to launch an recall earlier in the year of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first distributed between April 2016 and the beginning of this year.

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The incident of safety isn't an issue of recall. Avanos doesn't ask healthcare providers send the devices back however, it is a way to ensure they use them correctly.

A feeding tube that isn't correctly placed can result in severe injuries or even death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all related to FDA's use of the Cortrak*2 system to aid in the placement of the feeding tube.

Cortrak 2 eternal access system A variety of injuries have been described, which include respiratory failure (collapsed lung), lung infection and holes in the walls and esophagus.

In the March 21 field correction notice, the Georgia-based company advised users to "confirm the placement of nasogastric as well as Nasoenteric tubes in accordance with institutional policies," as per the FDA. Avanos has also asked users to attach the safety note to the operating manual for the system and confirm that they have received the latest update.

Avanos announced that they'll soon release updated labeling to the device. The label will contain the directions to put tubes according to their guidelines.

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Cortrak 2 eternal access system This marks the second warning the FDA has issued in the past year in regards to the use of enteral feeding tubes. In February, the FDA issued a safety warning to parents and healthcare providers regarding the danger of strangulation for children who are fed through tubes.

The announcement followed two instances of deaths in 2021. A tubing system that was not closely monitored by the staff or caregivers wrapped around the necks and necks of infants under two years old.

"While the FDA considers that strangulation caused by tubing for the feeding tube in children is not likely to cause fatal injury or death, caregivers and healthcare providers should be aware of the possibility," the FDA stated in the notice. The FDA also stated that similar incidents could not have been reported to the FDA.


Website: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns