Notes

Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This problem has resulted in 60 injuries and 23 deaths.

Avanos Mediacal Cortrak 2 The FDA has identified this as an Class I recall, which is the most severe type of recall. These devices can cause serious injuries or even death.

Avanos Mediacal Cortrak 2 Sam Brusco, Associate Editor05.16.22

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

Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or small bowels of patients needing to receive nutrition via tube.

In the wake of deaths and injuries due to injuries and deaths, the system was recall. An incorrectly placed nasogastric/nasoenteric tube can result in severe injury or death.

feeding tube placement According to Avanos the number of incidents has been an estimated sixty injuries and 23 deaths related to this issue. Some of the adverse events reported were respiratory failure, pneumothorax, perforation, pneumonia, and pleural effusion.

Cortrak 2 eternal access system Avanos Medical Cortrak*2 will utilize the recall to update its directions for usage and intended usage. It will advise users to verify tube placement using institutional protocols before delivering food.

Cortrak 2 eternal access system Clinicians are also advised to include the field correction notice to the operating manual , and return the acknowledgement forms included in the notice to Avanos. The users will shortly receive an update to the labels and confirmation that tubes were placed according to institution guidelines.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf
Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery