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Avanos Medical faces Class I recall due to feeding tube system connection up to 23 deaths.

After seven years of bad luck for the Avanos Medical enteral feeding tube placement system The FDA has handed down its most severe designation for a recall of the device.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. When they are used together, the system offers an live stream of the positioning of the medical feeding tube in the stomach of a patient or into their small bowel, with the aim of improving the accuracy of the tube's tip positioning and reducing the risk of complications.

Avanos was not pleased with its mission and launched a recall of all Cortrak*2 units used between January 2021 & January 2022. The recall included more than 630 units distributed in total between April 2016 and the start of this year.

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The incident that caused the safety issue is not a reason to issue the occurrence of a recall. https://tuffclassified.com/user/profile/1517509 Avanos has asked healthcare providers not to send the devices back at the manufacturer. But, they would like to ensure they are correctly making use of the devices.

Avanos Medical feeding tube The incorrect placement of a feeding tube could result in damage to the vocal cords, lungs, or the trachea. This could result in serious injuries, or death. Avanos Mediacal Cortrak 2 Avanos has reported more than 60 injury cases in 2015 according to the FDA. This was all due to the FDA's Cortrak*2 system, which guides placing feeding tubes.

Some of the injuries reported include respiratory failure, collapsed lung, lung infections, and holes within the walls of the lungs and esophagus.

https://escatter11.fullerton.edu/nfs/show_user.php?userid=2427640 According to FDA the Georgia-based company advised users in the March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes in accordance with institutional guidelines". They've also been asked to add the safety note to the system's operating manual and to confirm with Avanos that they have received the update.

Avanos said it will soon provide updated labels for the device. https://setiweb.ssl.berkeley.edu/beta/show_user.php?userid=10630079 It will contain the directions to determine a tube's placement in accordance with their facility's policies before using the system to help set up the tube.

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This is the second warning that the FDA has issued in the past year in regards to feeding tubes for the enteral system. In February, FDA published a safety announcement warning parents and healthcare providers about the potential for strangulation in children who use feeding tubes.

The announcement followed two instances of deaths in 2021. In both instances, a tubing system was found to accidentally wrap around the neck of a patient who was less than two years old when they weren't directly monitored by caregivers or hospital workers.

"While the FDA believes death or serious injuries caused by strangulation caused by enteral food set tubing for children is uncommon healthcare professionals and caregivers must be aware that such events could and do occur," the FDA noted in the notice.


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