Notes

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

The FDA has given the most severe of warnings in relation to the recall of Avanos Medical's Enteral Feeding Tube Positioning System.

Avanos Medical feeding tube Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver as well as a display monitor. It can be used in conjunction to stream a live video that shows the process of inserting a feeding tube into the stomach of an individual. This is done in the hope of increasing precision and reducing the risk of complications.

Avanos started an earlier this year, involving every Cortrak*2 piece of equipment that was that was used between January 2021 to Jan 2022. Avanos Medical feeding tube There were more than 630 devices originally distributed between April 2016 through the beginning.

RELATED
A tiny widget offers greater safety but creates chaos in tube feeders
The safety incident is not an actual recall, but rather a sense: Avanos does not ask healthcare providers to return the devices to the manufacturer. Avanos Mediacal Cortrak 2 Instead, it would like to ensure they're making use of the devices in a safe manner.

An incorrectly placed feeding tube could cause damage to vocal cords and lungs. It could also cause serious injury or even death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all of them related to the FDA's usage of the Cortrak*2 system to guide the placement of a feeding tub.

Some of the injuries reported include respiratory failure, lung collapse infected lung, as well as holes within the walls of the lungs and esophagus.

The FDA has reminded patients of the need to verify placement of nasogastric or nasoenteric tube according to their institutional guidelines in its March 21 field correction notification. Avanos has asked users to include a safety note in their operating manuals and verify that they've been updated.

Avanos announced that they would soon issue new labeling on the device. The label will contain the directions to put the tube in accordance with their guidelines.

RELATED
FDA issues an order requiring Philips to fix, replace, refund or exchange all ventilators that have been recalled.
This is the FDA's second caution in relation to feeding tubes for enteral nutrition. In February, FDA released a safety message informing parents and healthcare providers about the possibility of strangulation of children using feeding tubes.

Following two death reports in 2021, this warning was published. In both instances, a tubing system was discovered accidentally wrap around the neck of a child under the age of two when they weren't directly watched by the staff members or caregivers.

https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges "The FDA believes that strangulation by enteral feed set tubing children is rare, however, healthcare professionals and caregivers need to be aware that such events can and do happen," the agency stated in the announcement. This suggests that similar cases may not have been reported to FDA.

Avanos Medical
Read More: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding