Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have caused 23 deaths since 2015.

The FDA has issued its most severe warning in relation to the recall of Avanos Medical's enteral feeding tube positioning system.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver with a display monitor. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ The system provides a live feed of medical tubes that are inserted in patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and the elimination of any complications.

Avanos initiated a recall earlier in this year for the entire Cortrak*2 device that was used between January 2021 to Jan 2022. There were more than 630 devices initially distributed between April 2016 to the beginning.

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The incident that caused the safety issue does not constitute a recall. Avanos has asked healthcare providers not to send the devices back at the expense of the manufacturer. But, they would like to ensure they are correctly using the devices.

If a tube for feeding is placed incorrectly, it can damage the vocal cords, lungs or the trachea and cause severe injury or death. Avanos was informed of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. The incidents were all connected to the Cortrak*2 system that guides the positioning of feed tubes.

A variety of injuries have been described, including respiratory failure (collapsed lung) lung infection, holes in the esophagus's walls.

Avanos Medical In its March 21 field correction note, the Georgia-based business warned users to "confirm the placement of nasogastric as well as Nasoenteric tubes in accordance with institutional policies," per the FDA. Avanos recommended that patients attach the safety notice and confirm with Avanos that they have received the latest version.

feeding tube placement Avanos said it would soon issue updated labels for the device. They will contain the instructions for how to place a tube, according to their guidelines.

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This is the FDA's second caution regarding the use of an enteral tube for feeding use. Avanos Medical The FDA issued the safety announcement in February, warning parents and healthcare professionals about the danger of strangulation if children are using feeding tubes.

The notice was issued due to two deaths reported in 2021. In both instances the tubing system was discovered accidentally wrap around the neck of patients who was less than two years old when they weren't directly observed by their caregivers or hospital workers.

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

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
Website: 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