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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue has caused the deaths of 23 people and 60 injuries.

This recall is classed by FDA as a class I recall. This is the most serious type. https://musescore.com/user/50336507 These devices can lead to serious injuries and even death.

Avanos Medical Sam Brusco Associates Editor05.16.22

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

Cortrak*2 permits clinicians to insert medical feeding tubes inside the stomach or small bowel of patients who require nutritional assistance.

Due to the possibility of injuries or deaths caused by the system, it was removed. A mistake in the placement of an Nasogastric tube or Nasoenteric one could cause severe injury or even death.

According to Avanos Safety communications there were 60 injuries and 23 deaths attributed to this issue. Avanos Medical There were a variety of adverse events, such as pneumothorax, respiratory failure, perforation as well as pleural effusion and pneumonia.

Cortrak*2 will use this recall to improve its instructions for the use and intended usage. https://www.inventables.com/users/zachariassendowling6228 The users will have to verify the location of the tubes according to established protocols before they can deliver nutrition.

Avanos Medical feeding tube Clinicians were instructed to attach the appropriate field correction notice in the operating manual. Avanos Medical They must also return the acknowledgement sheet included with the Avanos notification. Avanos Medical feeding tube Avanos plans to provide users with current labeling, which will include confirmation of tube placement in accordance with the institution's policies prior to use.


Website: https://www.inventables.com/users/zachariassendowling6228
     
 
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