Notes

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

Seven years after poor luck with Avanos Medical's insertal feeding tube placement system for children, the FDA has issued its most serious warning regarding the recall of the device.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver as well as an LCD monitor. When combined will provide live footage of the medical feeding tube being placed in a patient's stomach.

Avanos announced a recall earlier in the year to all Cortrak*2 devices that were used from January 2021 and January 2022. This totaled nearly 630 devices, which was distributed for the first time in April 2016 to the beginning of the year.

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The safety incident isn't a recall in the strict sense of the word: Avanos is not asking healthcare providers to send the device back to its manufacturer, but to ensure that they're using them in a safe manner.

An incorrectly placed feeding tube can cause harm to vocal cords as well as lungs. It could also cause grave injury or even death. Avanos has reported more than 60 injury cases in 2015 as per the FDA. All of this was due to the FDA's Cortrak*2 system that guides the how to insert feeding tubes.

The most common injuries are respiratory failure and collapsed lung, lung infection the pleural effusion and holes in the lung's walls or esophagus, as well as the bowel.

According to FDA the Georgia-based company has reminded patients in its March 21 Field Correction Notice to "confirm the placement of nasogastric and Nasoenteric tubes as per institutional guidelines". Avanos is also asking them to attach the safety note to the operating guideline of the system and confirm that they have received the update.

Avanos has announced that they will soon issue updated labels for the device. These will include the instructions for how to position a tube, in accordance with their policies.

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The FDA has issued a second warning this year regarding tube feeding through the stomach. In February, the FDA issued an safety warning for parents and healthcare providers regarding the risk of strangulation to children who are fed through tubes.

Two deaths in 2021 were disclosed in the announcement. The notice was issued following two reports of deaths in 2021. In both instances the tubing system was discovered to have been placed around necks of patients who were under the age of 2.

Avanos Medical feeding tube Avanos Medical "While the FDA believes that death or serious injury caused by strangulation from tubing for feeding through the enteral system in children is uncommon, healthcare providers and caregivers should be aware of the fact that these incidents are possible and can happen," the agency said in the announcement and suggested that similar incidents may not have been reported to the FDA.


Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015