Notes

Avanos Medical is facing a Class I recall due to feeding tube system malfunctions that have resulted in 23 deaths since 2015.

Seven years after bad luck for the Avanos Medical enteral feeding tube system Avanos Medical's enteral feeding tube placement system, the FDA has issued its most severe designation for recalls of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause It also has an LCD monitor. Avanos Medical When they are used together it 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 aim of improving the accuracy of the tube's placement and reducing complications.

Avanos issued a recall earlier this month of all Cortrak*2 device that were used between January 20,21 between January 20,22 and January 20,21. The recall affected nearly 630 devices.

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The safety event isn't an actual recall, but rather a sense: Avanos does not ask healthcare providers to return the devices back to the manufacturers. Instead, it would like to ensure they're using the devices correctly.

Incorrectly inserting the tube could cause damage to vocal cords or lungs. According to the FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all related to FDA's usage of the Cortrak*2 system for guiding the installation of a feeding tube.

Numerous injuries have been reported such as respiratory failure (collapsed lung) lung infection, holes inside the esophagus and walls.

The FDA reminded users that they must confirm the placement of a nasogastric or nasoente tube according to their institution policies in its March 21 field correction notification. They've also been asked to add the safety note to the system's operating manual and confirm with Avanos that they've received the update.

Cortrak 2 eternal access system Avanos has stated that it will soon issue a new label for its device. Avanos Medical The labeling will be able to include directions to determine the location of the tube in line with their policies for their facilities.

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This is the FDA's third warning regarding enteral feeding tube use. In February, the FDA published the safety announcement warning parents and healthcare professionals of the dangers of strangulation as a result of the usage of tubes for feeding by children.

The notice was issued as a result of two deaths that were reported in 2021. In both instances, a tubing system was placed around the neck of a child while they were not being closely monitored by the hospital staff or caregivers.

Cortrak 2 eternal access system Avanos Medical feeding tube "The FDA believes that strangulation by enteral feed set tubing children is uncommon, but healthcare providers and caregivers need be aware that these events can and do happen," the agency stated in the notice. This indicates that similar incidents might not have been reported to FDA.


Here's my website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement