Notes

Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This has resulted in 60 injuries, and 23 deaths.

The FDA has classified this as an Class I recall, the most serious kind of recall. The devices could result in serious injuries and even death.

Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of the Cortrak*2 access device for use in the system. 629 devices distributed between 2016 to 2022 were recalled within the U.S., beginning on March 21.

Avanos Medical Cortrak*2 aids clinicians to place medical feed tubes on patients that require nutrition via the tube.

The device was temporarily recalled because of injury and death reports resulting from nasocentric and Nasogastric tube misplacement while it is employed to place these tubes. Cortrak 2 eternal access system If the tube is not properly placed, it can result in severe injury or death.

feeding tube placement According to Avanos the number of incidents has been an estimated 60 injuries and 23 deaths connected to this problem. Pneumothorax and pneumothorax (perforation), pneumonia, and pleural effusion have all been listed as adverse events.

Avanos Mediacal Cortrak 2 Cortrak*2 has utilized the recall to make updates to its guidelines for its use. Avanos Medical The new instructions include instruction to users to ensure that the tubes are placed according to the guidelines of the institution before applying them to provide nutrition.

Clinicians were also asked to attach the correct notice about the problem in the operating book and then return the acknowledgement form along with the note to Avanos. Avanos is hoping to offer users updated labeling. This will include confirmation that tube placement was done according to institutional guidelines.


My Website: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/