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

Seven years after bad results with the Avanos Medical's feeding tube placement system for children, the FDA has issued the most severe warning regarding the recall of this device.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver with a display monitor. feeding tube placement When combined the system provides an live stream of the positioning of medical-grade feeding tubes into the stomach of a patient, or in the small bowel with the aim of improving the accuracy of the tube's tip placement and reducing complications.

Avanos launched an earlier year, affecting all Cortrak*2 units that were used between January 2021 and January 2022. The total number of affected devices was 630. devices. They were distributed for the first time between April 2016 to the beginning of the year.

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The incident that caused the safety issue is not a reason to issue an recall. Avanos has asked healthcare providers not to return the devices back at the request of the manufacturer. https://www.supplychain.nhs.uk/icn/avanos-medical-uk-ltd-factory-closure-on-entral-branded-products/ However, they want to ensure they are correctly using the devices.

The incorrect placement of a feeding tube could cause injury to the vocal cords, lungs, or trachea. This could result in serious injury, or even death. Indeed, Avanos has received reports of 23 deaths and 60 injuries since the year 2015, the FDA said, all of which were related to the use of the Cortrak*2 system that guides the placement of the feeding tube.

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

According to FDA the Georgia-based company advised users in the March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes as per the policies of the institution". Avanos is requesting that users attach a safety notice to their operating manuals and verify they've updated their manuals.

Avanos Medical Avanos indicated that it will shortly issue new labels to the device. They will contain the direction of where to put the tube, according to their policies.

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This is the second FDA warning this year about enteral feeding tubes. In February, the FDA issued a safety alert for parents and healthcare professionals regarding the risk of strangulation to children who use feeding tubes.

The notice was issued as a result of two deaths that were reported in 2021. A tubing system that was not being controlled by caregivers or staff wrapped around the necks and necks of infants under two years old.

"While the FDA believes that death or serious injury due to strangulation caused by enteral feeding tubing in children is rare healthcare professionals and caregivers should be aware that such events are possible and can happen," the agency said in the announcement warning that similar cases may not yet had been reported to the FDA.

Avanos Medical
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