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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue is responsible for at the very least 60 injuries and 23 fatalities.

This recall has been identified by the FDA as a Class I recall. It is the most severe type of recall. These devices can lead to severe injuries or even death.

Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system for enteral access. Avanos Medical The recall of 629 devices distributed between 2016 and 2022 started on the 21st of March.

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

The system's recall was due to the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. These tubes are used to aid in the placement of them. Incorrectly inserting the Nasogastric or Nasoenteric tube could result in severe injuries or even death.

According to Avanos’ safety communication there were 60 deaths and 23 injuries that were related to the issue. Some of the adverse events reported were pneumothorax, respiratory failure perforation, pneumonia and the development of pleural effusion.

Avanos Mediacal Cortrak 2 https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The recall is used to revise Cortrak*2's guidelines regarding use and intended usage and to instruct users to verify tube placement based on protocol guidelines before using the tube to deliver nutrition.

Clinicians were directed to attach the appropriate field correction notice in the operating manual. Cortrak 2 eternal access system They should also return the acknowledgement sheet which came along with the Avanos notice. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause#:~:text=Reason%20for%20Recall,to%20help%20with%20their% 20placement. Cortrak 2 enteral access system Avanos is hoping to give users updated labeling. Avanos Medical feeding tube Avanos Medical feeding tube This will include confirmation that tube placement was performed in accordance with the institution's policies.


Here's my website: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf