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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This has led to 60 injuries and 23 deaths.

The recall has been classed by FDA as a class I recall. This is the most serious type. Avanos Medical These devices could lead to severe injuries or even death.

Sam Brusco Associates Editor05.16.22

The FDA has confirmed Avanos Medical's recall of their Cortrak*2 enteral access system. Avanos Mediacal Cortrak 2 Since March 21st the 21st of March, 2016, 629 devices were recalls in the U.S.

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

The device was removed because of injuries and death reports following nasocentric or Nasogastric tube misplacement, when the device is used to help place these tubes. An error in inserting an Nasogastric tube or Nasoenteric one can cause serious injury or even death.

According to Avanos Safety Communication the company has reported 60 injuries and 23 deaths related to this issue. feeding tube placement Pneumothorax (perforation), pneumothorax (perforation) and pneumonia and pleural effusion were all identified as adverse events.

Cortrak*2 will make use of the recall to update its directions for usage and intended use. It will advise users to verify tube placement with the help of institutional protocols prior to providing nutritional supplements.

feeding tube placement Clinicians were also urged to add the updated field notice regarding the problem to Avanos operating manual and return the acknowledgement forms included in Avanos' announcement. The company plans to offer users the most current labels, and also a confirmation of placement of tubes in accordance to institutional policies.


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