Notes

Avanos Medical is facing a Class I recall due to problems with the feeding tube system that have resulted in 23 deaths in the last year.

After seven years of bad results with the Avanos Medical's feeding tube placement system for children The FDA has issued its most serious warning regarding the recall of the device.

feeding tube placement Cortrak 2 eternal access system Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver as well as an LCD monitor. When combined this system allows you to see the actual installation of a medical feed tube into a patient's stomach.

Avanos issued an earlier this month a recall of all Cortrak*2 device used between January 20,21 between January 20,22 and January 20,21. It involved nearly 630 devices.

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The safety event isn't a recall in the literal sense of the word: Avanos is not asking health professionals to return the devices back to the manufacturer, instead, they want to make sure they're using them in a safe manner.

https://www.fcc.gov/fcc-bin/bye?https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ If a feeding tube is not properly inserted it could cause damage to the vocal cords, lungs or the trachea and cause severe injury or death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all of which were related to the FDA's use of the Cortrak*2 system to guide the placement of the feeding tube.

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

According to the FDA Avanos, a Georgia-based business issued a March 21 field correction note reminding users to verify the location of nasogastric tubes and tubs for the nasoenteric system according to institution policies. Avanos has asked patients to attach a safety notice to their operating manual and confirm that they've been updated.

Avanos announced that it will shortly issue updated labeling for the device, which will include a direction to map out the location of the tube in line the policies of their facility prior to making use of the system to assist install the tube.

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This is the second FDA warning on enteral feeding tubes this year. In February, the FDA issued a safety announcement warning healthcare providers and parents about the possibility of strangulation among children using feeding tubes.

After two deaths that occurred in 2021, the notice was issued. A tubing system wasn't being controlled by caregivers or staff was wrapped around necks and necks of infants under two years of age.

"The FDA believes that death and serious injuries resulting from strangulation using tubing for feeding tubes used in the enteral system for children is extremely rare. However, healthcare professionals, and caregivers, should be aware that such events can and do happen," the FDA said in its notice. The agency suggested that similar incidents might not yet have been reported to the FDA.

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