Notes

Avanos Medical faces Class I recalls in relation to 23 deaths resulting from the tube feeding system.

The FDA has issued the most severe of warnings regarding the recall of Avanos Medical's feed tube enteral positioning system.

Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html It also comes with the capability of displaying a screen monitor. The system, when combined, provides live video of the medical tube that is placed inside a patient's stomach.

Avanos Medical Avanos has announced a recall earlier this month of all Cortrak*2 devices that were used between January 20,21 between January 20,22 and January 20,21. The recall affected nearly 630 devices.

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The incident that caused the safety issue is not considered to be a recall. Avanos Medical Avanos Medical feeding tube Avanos has asked healthcare providers not to send the devices back to the expense of the manufacturer. Avanos Mediacal Cortrak 2 But, they would like to ensure they are correctly making use of the devices.

A tube for feeding that is not properly inserted could result in serious injuries or even death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries since 2015, all related to the FDA's use of the Cortrak*2 system for guiding the placement of a feeding tub.

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

In its March 21 field correction notice, the Georgia-based company warned users to "confirm placement of nasogastric and Nasoenteric tubes as per guidelines of the institution" according to the FDA. Avanos Mediacal Cortrak 2 Avanos has also asked them to attach the safety note to the operating guideline of the system and confirm that they've received the update.

Avanos stated that it will shortly issue a revised labeling for its device. It will also include instructions to indicate the location of the tube in line to the policies of their facility.

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This is the second warning the FDA has issued this year with regard to the use of enteral feeding tubes. In February, the agency released a safety message warning healthcare providers and parents of the risk of strangulation for children using tubes for feeding.

Following two reports of deaths in 2021, a notice was sent. In both cases, a tubing system was accidentally tied around the neck of a child even though they were not closely monitored by hospital staff or caregivers.

"While the FDA believes death or serious injuries resulting from strangulation with enteral food set tubing in children is uncommon healthcare professionals and caregivers need to be aware that these incidents can and will occur," the FDA noted in the notice.


Here's my website: https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/