Notes

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

Seven years after 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 recalls of the product.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver, and an LCD monitor. Avanos Medical When combined, provides live video of the medical feed tube being placed in the stomach of a patient.

Avanos began the recall earlier this year for the entire Cortrak*2 device that was used between January 2021 to Jan 2022. There were more than 630 devices initially distributed between April 2016 to the beginning.

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The incident that caused the safety issue is not a reason to issue an recall. Avanos Medical feeding tube Cortrak 2 eternal access system Avanos has asked healthcare providers to not send the devices back at the request of the manufacturer. However, they want to ensure they are correctly using the devices.

A feeding tube that is not properly inserted could result in serious injuries or even death. Avanos Medical feeding tube In actual fact, Avanos has received reports of deaths of 23 and 60 injuries since 2015 the FDA stated that all of them were related to the use of the Cortrak*2 system to guide the placement of a feeding tube.

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

According to the FDA Georgia-based Avanos issued a March 21 field correction notice reminding patients to confirm the position of nasogastric and nasoenteric tubs according to institutional policies. Avanos advised users to attach the safety notification to the operation manual of the system and confirm that they have notified Avanos that the change was approved.

Avanos has indicated that it will soon issue new labeling for the device. The labeling will be able to include the direction for mapping a tube's location in accordance their facility policies.

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The FDA has issued a second warning this year regarding the use of enteral feeding tubes. https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ In February, FDA released an safety alert warning parents and healthcare professionals about the possibility of strangulation in children who use feeding tubes.

Two deaths occurred in 2021 and were disclosed to the notice. In each case the tubing system was found to be wrapped around the neck of a patient under the age of two even though they were not being observed by their medical staff or caregivers.

"While the FDA believes that serious injury or death caused by strangulation from enteral feeding set tubing in children is uncommon healthcare professionals and caregivers should be aware of the fact that these incidents can and do occur," the agency said in the announcement warning that similar cases might not have been reported to the FDA.


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