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This issue is responsible for at least 60 injuries and 23 fatalities.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Mediacal Cortrak 2 This is an item classified as a Class I recall by FDA, which is the most severe type. Cortrak 2 eternal access system Use of these devices may cause serious injury or death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of access to the enteral. Starting on March 21 in 2016, 629 of the devices were recalled across the U.S.
Cortrak*2 aids clinicians when placing medical feeding tubes inside the stomachs or small bowels of patients that need to be fed by the tube.
The system was recalled due to injury and patient death reports resulting from nasocentric and Nasogastric tube misplacement while it is employed to help place these tubes. Avanos Mediacal Cortrak 2 Incorrectly inserting an Nasogastric tube or Nasoenteric one could cause severe injury or even death.
According to AvanosSafety Communication there were 60 deaths and 23 injuries related to the issue. Avanos Medical Some of the adverse events reported were pneumothorax, respiratory failure, perforation, pneumonia and the development of pleural effusion.
This recall is used to revise Cortrak*2's instructions for use, intended uses and also instruct users to confirm tube placement in accordance with institutional guidelines prior to making use of the tube to provide nutritional benefits.
Clinicians were advised to attach the corrective notice for field use concerning the issue to their operating manual and return the acknowledgment form that was enclosed in the notice to Avanos. Avanos plans to offer users the most current labels, and also a confirmation of tube placement in accordance with the institutional guidelines.
Cortrak 2 eternal access system
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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