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This problem has been the cause for the deaths of 60 people and 23 injuries.
Cortrak 2 eternal access system This recall was identified by the FDA as classified as a Class I recall. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ It is the most severe type of recall. These devices can lead to grave injuries, and possibly death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed the recall by Avanos Medical of Cortrak*2 entry access system. Since March 21st in 2016, 629 of the devices were recalled in the U.S.
Cortrak*2 assists clinicians in placing medical feed tubes into patients who require nutrition via the tube.
The system's recall was caused by injuries and deaths of patients due to an error in placement of the nasocentric or nasogas. These tubes are used to aid in the placement of them. A nasogastric, or nasoenteric, tube that is not correctly inserted could cause injury to the vocal cords or the trachea. feeding tube placement This could lead to severe injury or death.
As per Avanos safety communication the problem has led to sixty injuries and 23 deaths. https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of Pneumothorax, pneumothorax (perforation), pneumonia, and pleural effusion were all reported as adverse events.
https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Cortrak*2 will use this recall to update its instructions for the use and intended usage. The users will have to verify the location of tubes based on the protocols of institutions before they are able to deliver nutritional supplements.
Clinicians were urged to attach the corrective field notice concerning the issue to their operating manuals and return the acknowledgement form that was included with the notice to Avanos. The company is planning to provide users with current labeling, and also a confirmation of placement of tubes in accordance with the institutional guidelines.
Read More: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
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