Notes

Avanos Medical is facing a Class I recall due to problems with the feeding tube system that have caused 23 deaths since the year 2015.

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

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver, and an LCD monitor. Cortrak 2 eternal access system When combined with the display monitor, allows live video of the medical feeding tube being placed into a patient's stomach.

Avanos initiated a recall earlier in this year, involving every Cortrak*2 piece of equipment that was in use between Jan 2021 to Jan 2022. There were more than 630 devices initially distributed between April 2016 to the beginning.

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The safety event is not considered to be the occurrence of a recall. Avanos has asked healthcare providers not to send the devices back at the request of the manufacturer. However, they want to ensure they are correctly making use of the devices.

A tube for feeding that is not correctly placed can result in severe injuries or even death. Avanos was informed of more than 60 injuries and 23 deaths in the year 2015 by the FDA. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm The incidents were all linked to the Cortrak*2 system that guides the positioning of feed tubes.

There are many injuries that have been reported, like respiratory failure, collapsed lung, and lung infection.

Avanos Medical According to FDA the Georgia-based firm reminded users in the March 21 Field Correction Notification to "confirm the use of nasogastric tubes and nasoenteric tubes according to institutional guidelines". Avanos has asked users to add a safety warning to their operating manuals and verify they've updated their manuals.

Avanos stated that it will soon release a new labeling guidelines for its device. This will include directions to indicate the location of the tube in line to their facility's policies.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical RELATED
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The FDA has issued a second caution in relation to feeding tubes for enteral nutrition. In February, the FDA published the safety communications that warned parents as well as healthcare professionals about the risk of strangulation due to the use of feeding tubes by children.

Two deaths occurred in 2021 and were not reported to the notice. The notice was issued following two deaths in 2021. In both instances the tubing system was found to have been tied around necks of patients younger than age of 2.

"While the FDA believes that strangulation from tubing for the feeding tube in children is unlikely to result in death or serious injury, caregivers and healthcare providers should be aware of this possibility," the FDA stated in the notice. It also noted that similar cases may not have been reported to the FDA.


Homepage: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm