Notes

Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There were 60 injuries as well as 23 deaths related to this issue.

Avanos Medical feeding tube The FDA has declared this to be an Class I recall, which is the most serious type of recall. These devices can cause serious injuries or even death.

Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of its Cortrak*2 user access system. Beginning on March 21, 2016, 629 devices were recalled across the U.S.

Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or in the small bowel of patients who require nutrition via tube.

The device was temporarily recalled because of injury and death reports following nasocentric or nasogastric tube misplacement when the device is used to help put these tubes in the right place. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ feeding tube placement An error in inserting an Nasogastric tube or Nasoenteric one could result in severe injury or even death.

According to Avanos' safety communication, there have been 60 injuries and 23 deaths related to this issue. Numerous adverse events were identified which included pneumonia, respiratory failure and pneumothorax.

Cortrak*2 is using the recall to make changes to its instructions for use. The new instructions provide users with a way to make sure that tubes are placed in accordance with institutional protocols prior to applying them to provide nutrition.

Clinicians were instructed to attach the pertinent field correction notice in the operating manual. They must also return the acknowledgement slip that came with the Avanos note. feeding tube placement Avanos plans to provide users with updated labeling, including confirmation of tube placement according to institutional policies before the use.


Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/