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This problem has been the cause for 60 deaths and 23 injuries.
The FDA has identified this as a Class I recall, the most severe type of recall. https://independent.academia.edu/PutnamSunesen The devices could cause severe injuries or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 oral access system. 629 devices manufactured between 2016 until 2022 were recalls within the U.S., beginning on the 21st of March.
Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or in the small bowel of patients who require nutrition through the tube.
In the wake of deaths and injuries, the system was recalled. https://classifieds.lt/index.php?page=user&action=pub_profile&id=4284402 If the tube is not properly placed, it could cause severe injury or even death.
According to Avanos safety communication, this issue has caused sixty injuries and 23 deaths. Many adverse events were identified which included pneumonia, respiratory failure and pneumothorax.
Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 This recall will be utilized to modify Cortrak*2's guidelines on use, intended use, and advise users to ensure that the tube is placed as per institutional guidelines prior to making use of the tube to provide nutritional benefits.
https://www.misterpoll.com/users/avanos mediacal cortrak 2xbtu2179 Clinicians were also advised to include the field correction notice about the issue to the operating guideline and return the acknowledgement form that was included with the notice to Avanos. Avanos plans to offer users the most current labels, along with confirmation of placement of tubes in accordance to institutional policies.
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