Notes

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

Seven years after adversity for the Avanos Medical Enteral Feeding Tube Placement System, the FDA has issued its most severe designation for the recall of the device.

Avanos Medical feeding tube Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. The system can be utilized in conjunction with the system to show a live stream which shows the process of inserting a medical feeding tube into the stomach of the patient. Cortrak 2 eternal access system This procedure is carried out to improve the accuracy of the procedure and decreasing complications.

feeding tube placement Avanos issued an earlier year for all Cortrak*2 devices that were used from January 2021 to January 2022. The total number of affected devices was 630. devices. The devices were first distributed between April 2016 and the beginning of 2016.

The safety incident isn't recall in its true meaning: Avanos does not ask healthcare providers to return the devices to the manufacturer. Instead, it would like to ensure they're making use of the devices properly.

If a feeding tube is incorrectly placed, it could harm the vocal cords, lungs or the trachea and cause serious injury or death. https://notes.io/qiVtU According to FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all linked to the FDA's use of the Cortrak*2 system for guiding the installation of a feeding tube.

A few of the injuries that have been reported include respiratory failure, collapsed lung and lung infections, pleural effusion , and holes in the walls and esophagus, bowel, and lungs.

The FDA reminded users that they need to confirm the the placement of a nasogastric or nasoente tube according to their institutional guidelines in the March 21 field correction notice. The company also asked users to attach the safety notice to the system's operating manual and verify with Avanos that they have received the latest version of the notice.

Avanos announced that they will soon issue an updated labeling for the device. It will include the directions to put a tube according to their guidelines.

This is the FDA's second warning this year regarding the use of enteral feeding tubes. In February, the FDA issued a safety message informing healthcare professionals and parents of the possibility of strangulation when children are using feeding tubes.

After two deaths in 2021, a notice was issued. In both instances the tubing system was discovered accidentally wrap around the neck of a patient under the age of two when they weren't directly watched by the medical staff or caregivers.

Avanos Medical "While the FDA believes that strangulation caused by enteral feeding tube tubing in children is rare," the agency noted in the announcement. It suggested that other similar cases may not have been reported to the FDA.


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