Notes

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

Seven years after poor luck with Avanos Medical's insertal feeding tube placement system for children, the FDA has issued the most severe warning regarding the recall of this device.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver as well as an LCD monitor. It can be combined to stream a live video that shows the procedure of inserting a medical feed tube in the stomach of an individual. The procedure is performed with the aim of improving accuracy and reducing complications.

Avanos started a recall earlier in this year for all Cortrak*2 equipment used between Jan 2021 to Jan 2022. There were nearly 630 devices originally distributed between April 2016 to the beginning.

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Avanos Mediacal Cortrak 2 The safety incident is not a reason to issue a recall. Avanos has asked healthcare providers not to send the devices back at the request of the manufacturer. Avanos Medical But, they would like to ensure they are correctly using the devices.

A feeding tube that is not correctly placed can result in severe injuries or even death. Avanos has reported the deaths of 23 people and 60 injuries cases in 2015 according to the FDA. This is all because of the FDA's Cortrak*2 system, which guides how to insert feeding tubes.

A variety of injuries have been documented, including respiratory failure (collapsed lung), lung infection and holes within the walls and esophagus.

According to FDA the Georgia-based firm reminded users in its March 21 Field Correction Notification to "confirm placements of nasogastric & Nasoenteric tubes in accordance with institutional guidelines". Avanos has asked users to add a safety warning to their operating manuals and verify they have been updated.

Avanos announced that it will soon issue updated labeling for its product. feeding tube placement It will also include instructions for locating the position of the tube according to the policies of their facility.

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This is the FDA's second warning about enteral feeding tube use. In February, the FDA released an safety announcement informing parents and health professionals about the risk of strangulation as a result of the use of feeding tubes by children.

Two deaths occurred in 2021 and were disclosed to the notice. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Each time the notice was followed by two deaths in 2021.

"The FDA believes that strangulation via enteral feed set tubing children is uncommon, but healthcare providers and caregivers need be aware that such instances can occur and can happen," the agency stated in the announcement. This indicates that similar incidents might not have been reported to FDA.


Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/