Notes

Avanos Medical faces Class I recalls in connection to 23 deaths related to the tube feeding system.

After seven years of adversity for Avanos Medical's feed tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has handed down the most serious of designations for recalls of the device.

Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. Cortrak 2 eternal access system When they are used together the system provides live video feeds of the positioning of the medical feeding tube in the stomach of a patient or into their small bowel with the intention of improving the accuracy of the tube's placement and reducing complications.

Avanos began an earlier this year for the entire Cortrak*2 device in use between Jan 2021 to Jan 2022. There were more than 630 units originally distributed from April 2016 to the beginning.

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The safety event is not a reason to issue a recall. Avanos has asked healthcare providers not to send the devices back to the expense of the manufacturer. But, they would like to ensure they are correctly using the devices.

Incorrectly inserting a feeding tube could cause injury to the vocal cords, lungs, or the trachea. Avanos Medical This could lead to serious injury, or even death. Avanos recorded more than 23 deaths and 60 injuries in 2015, the FDA stated. All of these incidents were connected to the FDA's Cortrak*2 device used to insert the feeding tube.

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

According to FDA, Georgia-based company has reminded patients in its March 21 Field Correction Notification to "confirm placements of nasogastric & Nasoenteric tubes as per institutional guidelines". Avanos Mediacal Cortrak 2 Avanos is also asking them to attach the safety note to the operating guideline of the device and verify that they've received the latest update.

Avanos said it would soon issue updated labels for the device. They will contain instructions on how to position a tube, in accordance with the company's policies.

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This is the FDA's second caution regarding the use of an enteral tube for feeding use. In February, the FDA issued the safety communication informing parents and health professionals of the dangers of strangulation as a result of the usage of tubes for feeding for children.

Two deaths in 2021 were reported to the notice. Each time, the notice was followed by two deaths in 2021.

"While the FDA believes that death or serious injuries from strangulation with enteral food set tubing in children are rare healthcare professionals and caregivers should know that these events can and will occur," the FDA noted in the notice.


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