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

After seven years' of failures with Avanos Medical's Enteral Feeding Tube Placement Systems Avanos Medical's Enteral Feeding Tube Placement System has failed for FDA has assigned the most severe category for recalls.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and a monitor for display. The system can be used in conjunction to show a live stream that shows the procedure of inserting a medical feed tube in the stomach of a patient. This is done with the aim of improving precision and reducing the risk of complications.

Avanos issued a recall earlier this month of every Cortrak*2 device that was used between January 20,21 until January 20,22. The recall involved more than 630 devices.

The incident involving safety isn't recall in the literal sense. Avanos doesn’t ask healthcare providers send the devices back at the factory. Avanos Medical Avanos wants them to utilize the devices properly.

Avanos Medical feeding tube A feeding tube that is not correctly placed can result in serious injuries and even cause death. Avanos was informed of the deaths of 23 people and injuries to 60 in 2015 by the FDA. Avanos Medical feeding tube These events were all related to the Cortrak*2 system, which guides the installation of the feeding tube.

Avanos Medical There are several injuries that have been documented which include respiratory failure, lung infections and collapsed lung.

According to FDA, in the March 21 Field Correction Notice the Georgia-based company asked users to "confirm the placement of the nasogastric (and nasoenteric) tubes in accordance with institutional policy." They've also been asked to add the safety note to the operating manual for the system and confirm with Avanos that they have received the update.

Avanos Medical feeding tube Avanos announced that they'll soon release updated labeling to the device. Avanos Medical The label will contain the instructions for placing the tube in accordance with their policies.

This marks the second warning that the FDA has issued this year with regard to feeding tubes for the enteral system. The FDA issued a safety message in February, advising healthcare professionals and parents about the potential for strangulation of children who feed tubes.

The warning came following two deaths were reported in 2021. In each case the tubing system was discovered to accidentally wrap around the neck of patients younger than 2 when they weren't directly observed by their staff members or caregivers.

"While FDA believes that death from strangulation resulting from enteral feeding set tubing for children is uncommon It is crucial that caregivers and healthcare providers are aware that these events can and do happen," the FDA stated in the notice. The agency suggested that similar incidents might not yet have been reported.

Avanos Mediacal Cortrak 2
Homepage: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview