Notes

Avanos Medical faces Class I recalls for its feeding tube system linked to 23 deaths since 2015.

After seven years of unlucky luck for the Avanos Medical enteral feeding tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has handed down its most serious designation for a recall of the device.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. Avanos Medical feeding tube Avanos Medical When they are used together it provides a live feed of the process of inserting a medical feeding tube into a patient's stomach or small bowel, with the goal of improving the precision of the tube's placement and reducing the risk of complications.

Avanos began a recall earlier in this year for all Cortrak*2 equipment in use between Jan 2021 and Jan 2022. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ There were nearly 630 devices originally distributed between April 2016 through the beginning.

The incident that caused the safety issue does not mean that there is a recall. Avanos has asked healthcare providers not to send the devices back to their manufacturer. Avanos Medical Avanos only wants to ensure that the devices are properly used.

A feeding tube installed incorrectly can result in injuries to vocal cords or the tracheas. Avanos was informed of the deaths of 23 people and injuries to 60 in 2015 by the FDA. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system These incidents were all related to the Cortrak*2 system that controls the positioning of the feeding tube.

Avanos Mediacal Cortrak 2 The most common injuries are respiratory failure and collapsed lung, lung infection, pleural effusion, and holes in the walls of the lungs as well as the esophagus and bowel.

In the March 21 field correction announcement, the Georgia-based firm reminded users to "confirm placement of nasogastric and nasoenteric tubes according to institutional policies," according to the FDA. Avanos advised that patients attach the safety notice and confirm with Avanos they have been up-to-date.

Avanos announced that they would soon issue updated labeling to the device. The label will contain the directions to put the tube in accordance with their policies.

This is the second FDA warning this year regarding tube feeding through the stomach. In February, FDA issued a safety advisory to parents and healthcare providers about the risk of strangulation for children who are using feeding tubes.

The warning came following two deaths were reported in 2021. In both instances the tubing device was discovered be wrapped around the neck of patient under 2 years old, while they were not being watched by caregivers or hospital workers.

"While the FDA believes that strangulation caused by enteral feeding tube tubing in children is uncommon," the agency noted in the announcement. It suggested that other similar cases may not have been reported yet to the FDA.


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