Notes

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

After seven years in which Avanos Medical's intravenous tube placement device was plagued by unfortunate luck, the FDA has given the most important instruction to recall the product.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with the capability of displaying a screen monitor. It provides a continuous stream of medical tube feeding being placed into the stomachs of patients or small bowels. This allows for increase in the accuracy of tip placement and reduces the risk of complications.

Avanos issued an earlier year to all Cortrak*2 devices which were in use between January 2021 and January 2022. It was nearly 630 devices. The devices were distributed for the first time between April 2016 to the beginning of 2016.

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The incident that caused the safety issue is not a reason to issue a recall. Avanos has asked healthcare providers to not send the devices back to the manufacturer. But, they would like to make sure they are using the devices.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm An incorrectly placed feeding tube can cause harm to vocal cords as well as the lungs. It can also result in grave injury or even death. Avanos has reported 23 deaths and 60 injury cases since 2015 according to the FDA. This is all due to the FDA's Cortrak*2 system, which guides placement of feeding tubes.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 There are several injuries that have been reported, like respiratory failure, collapsed lung, and lung infection.

In the March 21 field correction notice, the Georgia-based company reminded users to "confirm the placement of nasogastric as well as Nasoenteric tubes as per the policies of the institution," as per the FDA. Avanos has also asked users to add the note on safety to the operating manual for the system and confirm that they've received the update.

Avanos has announced it will soon provide updated labels for the device. It will include a direction to determine the tube's location in accordance the policies of their facility prior to using the system to help to install the tube.

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The FDA has issued a second warning about enteral feeding tubes this year. Avanos Medical feeding tube The FDA issued an safety communication in February that warned parents and healthcare professionals about the risk of strangulation in the event that children are feeding tubes.

This notice was issued in response to two deaths reported in 2021. A tubing system wasn't being closely monitored by the staff or caregivers wrapped around the necks and necks of children less than two years of age.

"The FDA believes that strangulation via enteral feed set tubing in children is not common, however healthcare professionals and caregivers need be aware that these instances can occur and can occur," the agency stated in its notice. This suggests that similar cases may not have been reported to FDA.


Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause