Notes

Cortrak 2 EAS of Avanos Medical Raises Patients Safety Risks
Cortrak Medsystems Cortrak 2 device.

Avanos Mediacal Cortrak 2 Of the 51 MDRs 11, 11 patients died as a result of misuses of the Cortrak 2 device.

Recently, Fox News revealed that Avanos Medical has issued an error-in-field notice regarding its Cortrak 2 EAS, due to possible fatal results.

This highlights the serious risks of feeding tubes and their impact on human life.

Cortrak 2 eternal access system This could result in an investigation by the Food and Drug Administration.

Avanos Medical was charged with fraud in misbranding. It's not the first time they have misbehaved with FDA
Because of its direct impact on human lives, the medical devices industry is among the industries that is most tightly controlled.

Avanos Medical feeding tube There are, however, alarming cases in the field despite these rules.

Although the name "Avanos Medical" may not be a familiar one, if you are an avid reader of medical device industry news, you may have heard about a case involving the company.

Avanos sold hundreds of thousands of MicroCool surgical clothing , misbranded between November 2014 & January 2015.

They claimed that MicroCool surgical gowns were able to be protected from fluid and virus penetration and meet FDA's strictest standards. However, this claim was not true as the surgical gowns failed viral penetration tests, and the company was altering the sealing methods used to seal the gowns.

All this was revealed in July 2016 , when the FDA was investigating Avanos"surgeon's gown business.

To fool FDA they found fraudulent company records that an employee had created.

These poorly-designed devices caused injuries to hundreds.

Avanos should have known that the MicroCool surgical gowns weren't the most safe against virus penetration. They claimed that they were and even falsified their documents.

Be aware that the medical profession is not a safe profession. It is impossible to know how many lives affected by their actions.

Avanos Medical is available for consultation
Avanos Medical paid $22 million in July 2021 in the context of the Data Processing Agreement. This was to resolve the charge of felony.

Avanos has entered into an informal agreement with the Department of Justice to defer the prosecution of criminal offenses under the Federal Food, Drug & Cosmetic Act.

Avanos's products have caused problems for years.

They have been penalized multiple times by the FDA as well as the DOJ for criminal activities associated to issues with their products. Despite the efforts of the agencies, there are many who are still experiencing issues with their products.

Patients must be comfortable when using medical equipment. Patients don't have to be concerned about which medical device will cause death first.

Avanos as well as other medical device companies pose danger to the health of patients if they're not exposed.

The company is accused of criminal behavior in a variety of instances. They have to be held accountable.

Avnos Medical Issues, a field correction notice about the Cortrak 2 EAS

As earlier stated, Avanos medical is responsible for manufacturing the Cortrak 2 feeding tube.

Like surgical gowns and feeding tube placement devices such as the Cortrak 2 can save lives.

There has been concern about all medical devices produced by Avanos Medical because of the misbranding of MicroCool surgical gowns.

The concerns raised were valid.

Avanos offered a free field correction to Cortrak 2 EAS. Unfortunately it could have led in injury, or death.

Ironically, Avanos Medical claims their system helps to prevent this from happening by using screen visualization and location information during the placement of the tube. They can do this without the need to get x-ray confirmation.

Fox News reported that Avanos confirmed in a conversation with Fox News that they are currently engaged in an "ongoing discussion" with FDA regarding the issue.

They claimed that they could not comment and stated that the FDA has not requested to recall any products.

Avanos Medical It is essential to exercise extreme caution in the use of medical devices, such as the Cortrak 2 which have raised concerns.

Cortrak 2 eternal access system It has been demonstrated that Cortrak 2 can cause severe injury and even cause the end of the lives of patients.

Despite the modifications which Avanos Medical claims to make changes to their manufacturing and approval processes for medical devices medical professionals and patients cannot be certain of the safety of these products.

Avanos Medical offices should be visited by the FDA and the Department of Justice in order to ensure the safety of the families of patients.
Homepage: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system