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There were 60 injuries as well as 23 deaths due to this problem.
Cortrak 2 eternal access system This recall has been identified by the FDA as a Class I recall. It is the most severe type of recall. These devices can cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 useal access system. 629 devices manufactured between 2016 and 2022 were recalled within the U.S., beginning on the 21st of March.
Cortrak*2 aids clinicians to place medical feeding tubes inside the stomach or small bowels of patients needing to receive nutrition through the tube.
https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ The recall of the system was due to the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. Avanos Medical feeding tube Avanos Medical feeding tube These tubes assist in placing them. Avanos Medical feeding tube If a nasogastric or nasoenteric tube is incorrectly inserted there could be damage to the vocal cords, lungs or the trachea, leading to severe injury or death.
Cortrak 2 eternal access system According to Avanos' safety communication, there have been 53 deaths and 60 injuries related to this issue. Many adverse events were reported which included respiratory failure, pneumonia, and pneumothorax.
This recall will be utilized to modify Cortrak*2's guidelines regarding use, intended usage and also remind users to ensure that the tube is placed as per institutional guidelines prior to using the tube in order to provide nutritional benefits.
Cortrak 2 eternal access system 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. Avanos Medical Avanos plans to give users current labels, along with confirmation of the placement of the tube according to the policies of the institution.
Homepage: https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/
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