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Avanos Medical and the FDA have issued a Class 1 recall for approximately 629 units of the CORTRAK*2 Entral Access System, a feeding tube placement device that is associated with dozens of injuries and deaths.
The devices affected were distributed between April 1 in 2016 and January 1, 2022. Avanos Medical Avanos Medical feeding tube https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx These devices can be utilized by health professionals to put feeding tubes into the stomach or the intestines.
Cortrak 2 eternal access system Incorrect placement of the nasogastric or Nasoenteric tube was the source of 53 deaths and 60 injuries in the last year.
Avanos Medical This recall will be used to update the label on the device in order to remind users to ensure that the tube was correctly placed before they can deliver the food.
According to FDA, adverse events included respiratory failure or pneumothorax (collapsed lung), perforation [a hole in the wall or bowel of the lung], pneumonia (a lung infection) and Pleural effusion (excess liquid in the lung space and the chest cavity).
For more information, customers with questions or concerns about this recall should contact Avanos Medical by phone at 470-448-5444 or by emailing [email protected]. Cortrak 2 eternal access system
Website: https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx
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