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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There have been 60 injuries and 23 deaths related to this problem.

The recall is classified by FDA as a class I recall. This is the most serious type. These devices can cause serious injury or even death.

Sam Brusco, Associate Editor05.16.22

The FDA has discovered the recall by Avanos Medical of Cortrak*2 enteral access system. 629 devices, which were distributed between 2016 and 2022, were recalled by the U.S. starting on March 21.

Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowels of patients who need to be fed via the tube.

The system's recall was due to the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. These tubes assist in insertion. An error in inserting the Nasogastric or Nasoenteric tube could result in severe injury or death.

According to Avanos Safety Communication the company has reported 53 deaths and 60 injuries related to this issue. Avanos Medical Avanos Medical https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf A variety of adverse events were reported such as respiratory failure, pneumonia and pneumothorax.

Cortrak*2 will utilize the recall to update its guidelines for use and intended uses. Avanos Medical feeding tube Avanos Medical feeding tube It will also instruct users to check the placement of tubes by using protocols established by institutions prior to delivering food.

Clinicians are also advised to attach the field correction notice to the operating manual , and return the acknowledgement form included in the notice to Avanos. Avanos Medical The company is expected to be able to provide updated labeling to users, including confirmation of the placement of tubes according to the policies of the institution.


Read More: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf