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The issue has caused at least 60 injuries , and 23 fatalities.
feeding tube placement The FDA has declared this a Class I Recall, which is the most severe type. Avanos Medical These devices could cause serious injuries or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of access to the enteral. 629 of the devices produced between 2016 until 2022 were recalls, the first recall taking place on the 21st of March.
Cortrak 2 eternal access system Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or in the small bowels of patients needing to receive nutrition via the tube.
The device was temporarily recalled due to injury and patient death reports following nasocentric or nasogastric tube misplacement when it is employed to help place these tubes. An incorrectly placed nasogastric/nasoenteric tube can result in severe injuries or even death.
According to Avanos the number of incidents has been a total of 60 injuries and 23 deaths related to this issue. feeding tube placement The adverse events that were identified included respiratory failure, perforation, pneumonia, as well as the development of pleural effusion.
Avanos Medical feeding tube Cortrak*2 has used this recall to update the instructions for its the use and intended usage. Avanos Medical Users must verify the location of the tubes according to institutional protocols, before they are able to deliver nutritional supplements.
Clinicians were requested to attach the notice of correction about the problem in the operating book and then return the acknowledgement form along with the note to Avanos. The company plans to give users current labeling, and also a confirmation of tube placement in accordance with the institutional guidelines.
Avanos Medical
My Website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/
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