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Avanos Medical faces Class I recall for feeding tube system connected to 23 deaths in 2015

The FDA has issued its most severe warning regarding the recall of Avanos Medical’s enteral feeding tube positioning system.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also comes with a monitor for display. The system provides a live feed of medical feeding tubes that are inserted in patients' stomachs or small bowels. This facilitates the improvement of tip placement precision and elimination of any complications.

Avanos initiated an earlier this year, involving all Cortrak*2 devices that was used between January 2021 to Jan 2022. There were 630 units distributed between April 2016 through the beginning.

The incident that caused the safety issue does not constitute an recall. Avanos has asked healthcare providers not to return the devices to their manufacturers. Avanos only wants to make sure that the devices are utilized correctly.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Medical If a feeding tube is not properly placed, it could damage the vocal cords, lungs or the trachea which could result in severe injury or even death. Avanos has reported more than 60 injury cases in 2015 according to the FDA. This was all due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

These injuries can include respiratory failure, collapsed lungs lung infection, and holes within the lung's walls and esophagus.

Cortrak 2 eternal access system https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ The FDA advised users of the need to verify the placement of a nasogastric or nasoente tube in accordance with their institution guidelines in its March 21 field correction notification. Avanos has also asked users to add the safety notice to the operating manual for the device and to confirm that they have received the latest update.

Avanos has stated that it will soon issue a new label for the product. This will include the directions for locating the tube in accordance with their policies for facilities.

Avanos Medical The FDA has issued a second warning in relation to feeding tubes for enteral nutrition. In February, the agency put out a safety communication warning healthcare providers and parents of the risk of strangulation when children use feeding tubes.

This announcement was made in response to two deaths reported in 2021. In both cases, a tubing device was found to be wrapped around the necks of patients who were less than 2 years old while they were not being watched by hospital staff or caregivers.

"While the FDA considers strangulation caused by enteral feed set tubing in children is rare healthcare professionals must be aware of such incidents," the agency stated in the announcement. This suggests that similar instances might not have been reported to the FDA.


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