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Avanos Medical faces Class I recalls due to the feeding tube system's connection to 23 deaths.

After seven years' of failure in Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placement Systems, the FDA has issued the most significant recall orders.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver and an LCD monitor. When used together the system provides a live feed of the positioning of medical-grade feeding tubes into the stomach of a patient, or in the small bowel, with an goal of improving the precision of the tube's tip positioning and reducing the risk of complications.

Despite this goal, however, the system has been linked to numerous injuries to patients, leading Avanos to issue an recall earlier in the year of all Cortrak*2 units used between January 2021 to January 2022. This totals nearly 630 devices first released between April 2016 and the start of this year.

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The safety incident is not a recall in its literal meaning: Avanos does not ask healthcare providers to return the devices back to the manufacturers. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Instead, it wants to make sure users are using the devices correctly.

The incorrect placement of the feeding tube can result in damage to vocal cords or the lungs. According to the FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all of which were related to FDA's usage of the Cortrak*2 system to aid in the placement of the feeding tube.

Avanos Mediacal Cortrak 2 The injuries reported include respiratory failure as well as collapsed lung, lung infection as well as pleural effusion. holes in the lungs' walls, esophagus and bowel.

Cortrak 2 eternal access system According to FDA the Georgia-based company reminded users in its March 21 Field Correction Notification to "confirm the use of nasogastric tubes and nasoenteric tubes according to institution policies". Avanos asked users to include the safety notice in the system's operation manual and confirm with Avanos that the update was accepted.

Avanos announced that they will soon issue new labeling on the device. The label will contain the instructions for placing a tube according to their guidelines.

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The FDA has issued a second warning about enteral feeding tube use. In February, the FDA released an safety announcement warning parents and health professionals about the risk of strangulation as a result of the usage of tubes for feeding by children.

This notice was issued as a result of two deaths in 2021. The notice was issued following two reports of death in 2021. Avanos Mediacal Cortrak 2 https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery In each case, the tubing system was discovered to have been tied around necks of patients younger than age of 2.

"While the FDA believes that the risk of serious injury or death caused by strangulation from enteral feeding set tubing for children is extremely rare healthcare professionals and their caregivers must be aware that such events could and do happen," the agency said in the notice warning that similar incidents may not have been reported to the FDA.


Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system