Notes

Avanos Medical faces Class I recalls due to the feeding tube system's connection to 23 deaths.

The FDA has given the most extreme warning regarding the recall of Avanos Medical’s Enteral Feeding Tube Positioning System.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and an LCD monitor. The system allows you to see the live positioning of a medical feed tube in a patient's stomach.

Avanos was not satisfied with its mission and launched a recall of all Cortrak*2 units between January 2021 and January 2022. The recall included nearly 630 devices which were distributed between April 2016 and the beginning of the year.

The safety issue isn't a recall, in the literal sense. Avanos Medical feeding tube Avanos doesn’t ask healthcare providers to return the devices to the manufacturer. Avanos wants them to make use of the devices in a safe manner.

Avanos Mediacal Cortrak 2 A feeding tube that is not properly installed can result in injuries to vocal cords or tracheas. Avanos was alerted of 23 deaths and 60 injuries in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system that guides the positioning of the feeding tube.

Some of the injuries reported include respiratory failure, collapsed lung, lung infections, pleural effusions and holes in the walls, esophagus, bowel, and lungs.

The FDA advised users that they must confirm the placement of a nasogastric or nasoente tube according to their institutional policies in its March 21 field correction notification. Avanos asked users to include the safety notice in the system's operation manual and verify with Avanos that the update was approved.

Avanos Medical Avanos has announced that they will soon release updated labels for the device. Cortrak 2 eternal access system They will contain the direction of where to put the tube in line the policies of Avanos.

This is the FDA’s second warning regarding the use of enteral feeding tubes this year. The FDA released the safety communication in February, warning parents and healthcare professionals of the risk of strangulation when children are feeding tubes.

The notice was issued as a result of two deaths in 2021. Each incident involved a tubing system that was accidentally tied around the neck of a child less than 2 years old, while the baby was not being watched by hospital staff.

"While the FDA believes that the risk of serious injury or death caused by strangulation from enteral feeding set tubing in children is rare Healthcare professionals and caregivers should be aware that these events can and do occur," the agency said in its notice warning that similar cases may not yet had been reported to the FDA.

https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
Homepage: https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/