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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There are 60 reported injuries and 23 deaths related to this issue.

Avanos Medical The FDA has classified this as an Class I recall, which is the most serious kind of recall. Use of these devices may cause serious injury or 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 made between 2016 until 2022 were recalls, with the first recall occurring on the 21st of March.

Cortrak*2 helps clinicians place medical feed tubes in patients who require nutrition via the tube.

The recall was triggered by injury and death reports of patients suffering from nasocentric/nasogastric tube misplacement. This device is utilized to aid in the placement of the tubes. A mistake in the placement of an Nasogastric tube or Nasoenteric one could cause severe injury or even death.

Avanos Medical As per Avanos safety communication the issue has resulted in 60 injuries and 23 deaths. The adverse events that were reported include pneumothorax, respiratory failure, perforation, pneumonia, and the pleural effusion.

Cortrak*2 is using the recall to make updates to its guidelines to use. The updated guidelines will contain instructions for users to ensure that the tubes are placed in accordance with institution protocols before making use of them to deliver food.

Clinicians were also advised to add the updated field notice regarding the problem to Avanos operating manual and return the acknowledgement forms with Avanos' announcement. Cortrak 2 eternal access system Avanos will shortly be able to send out updated labeling to users, including confirmation of the placement of tubes as per institutional policies.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding feeding tube placement
Here's my website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/