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This issue has been responsible for the deaths of 60 and 23 injuries.
This recall has been classified by FDA as a class I recall. This is the most serious kind. These devices could cause serious injury or even death.
Avanos Medical http://hawkee.com/profile/2890783/ Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical's recall of their Cortrak*2 intramuscular access system. The recall of 629 devices distributed from 2016 to 2022 began on March 21.
Avanos Medical feeding tube Avanos Mediacal Cortrak 2 https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/45476984 Cortrak*2 is a tool that allows doctors to insert medical feeding tubes in patients' stomachs or small bowels.
The recall was triggered by death and injury reports from patients who suffered from nasocentric or nasogastric placement error. https://independent.academia.edu/VistisenHoffmann This device is used for helping to place these tubes. A mistake in the placement of the Nasogastric or Nasoenteric tube can cause serious injuries or even death.
http://sc.sie.gov.hk/TuniS/www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ According to Avanos, there have been a total of 60 injuries and 23 death related to this issue. The adverse events that were reported include respiratory failure, pneumothorax, perforation, pneumonia, and the pleural effusion.
Cortrak*2 will use this recall to update the guidelines for the use and intended usage. The users will have to verify the location of tubes in accordance with the protocols of institutions before they can be used to provide nutrition.
Clinicians were also advised to attach the field correction notice to the operating manual and return the acknowledgement form included with the notification to Avanos. The users will shortly receive an update to the labels and confirmation that tubes were placed in accordance with the institution's guidelines.
Read More: https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/45476984
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