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Avanos Medical faces Class I recall for feeding tube system that has been linked to 23 deaths since 2015

After seven years of unlucky luck for Avanos Medical's enteral feeding tube placement device The FDA has given the most serious of designations for a recall of the product.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and a display monitor. Avanos Medical feeding tube placement Together with the display monitor, it allows you to see the actual placement of a medical feed tube in the stomach of a patient.

Avanos was not satisfied with its mission and launched a recall of all Cortrak*2 units between January 2021 and January 2022. feeding tube placement The recall covered nearly 630 devices which were distributed between April 2016 & the start of this year.

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The safety incident isn't a recall in the literal sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer but to ensure that they're using the devices correctly.

A feeding tube that is not properly placed could result in damage to the vocal cords, lungs or the trachea. This can lead to serious injuries, or death. In actual fact, Avanos has received reports of more than 60 injuries since 2015 the FDA said, all of which were related to the use of the Cortrak*2 system that guides the placement of a feeding tube.

There are several injuries that have been reported such as respiratory failure, collapsed lung, and lung infection.

According to FDA, in its March 21 field correction notice, the Georgia-based firm warned users to "confirm the placement of nasogastric and nasaloenteric pipes in accordance with the institution's policies". Avanos is also asking them to add the note on safety to the operating guideline of the device and to confirm that they have received the updated.

Avanos indicated that it will shortly issue new labels to the device. They will contain instructions on where to put the tube, in accordance with their guidelines.

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This is the FDA’s second caution in relation to tube feeding through the stomach. In February, FDA released an safety alert to parents and healthcare professionals about the potential for strangulation among children using feeding tubes.

Cortrak 2 eternal access system This notice was issued due to two deaths that were reported in 2021. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ In both cases, a tubing system was tied around the neck of a child even though they were not closely observed by the hospital staff or caregivers.

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


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