Notes

Cortrak 2 EAS by Avanos Medical Boosts Patient Safety
Cortrak Medsystems Cortrak 2 device.

11 patients of the MDRs 51 were killed by misuses of Cortrak 2 devices.

Fox News just recently reported that Avanos Health had issued an update to the Field Correction Notice for its Cortrak2EAS due to the possibility of deadly consequences.

This is a stark reminder of the dangers of the industry which feeds the tube as well as its impact on the lives of people.

Avanos Medical feeding tube This could lead to an investigation by the Food and Drug Administration.

Avanos Medical was not the only one to mess with the FDA. https://www.fcc.gov/fcc-bin/bye?https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding A criminal charge was filed against the firm for fraudulent misbranding.
The impact of medical devices on the lives of humans is what makes it among the most highly monitored industries around the world.

However, there are troubling cases in the industry despite these rules.

While the name "Avanos medical" might not seem immediately obvious, it is possible that you've been reading about medical devices to read about a story concerning this company.

From November 2014 until January 2015, Avanos sold hundreds of thousands of counterfeit MicroCool surgical gowns.

https://dohabb.com/index.php?page=user&action=pub_profile&id=2592467 According to them, the MicroCool surgical gowns met the strictest standards established by the FDA and effectively protected against fluid and virus penetration. But, this claim was a lie since the gowns failed the tests to determine if they penetrated virally. The company also changed its sealant methods.

All this was revealed in July 2016 when the FDA investigated Avanos' surgical gown business.

To deceive FDA they found fraudulent company records that an employee had made.

https://www.inventables.com/users/albrechtsenmoody8539 Many people were injured because of these defective and poorly created devices.

If Avanos was aware they were not able to prove that their MicroCool surgical gowns do not offer the greatest protection against the penetration of viruses and fluids Why did they make this claim, and then fake documents?

https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ Medical professionals are delicate and many lives have been lost due to their actions.

Contact Avanos Medical for more information
Avanos Medical, in July 2021, agreed to pay $22,000,000 as part of a Data Processing Agreement. (DPA). The agreement was signed to stop this felony conviction.

Avanos signed an agreement for deferred prosecution (DPA) with the Department of Justice for criminal violations of Federal Food, Drug & Cosmetic Act.

Avanos Medical Avanos is currently experiencing problems in its products.

Multiple times, they were repeatedly cited by FDA and DOJ for criminal activity connected to issues with their goods. Despite all of these efforts, consumers continue to have problems with the company's products.

Patients need to feel secure making use of medical devices. They don't need to worry about who will kill their first, the medical devices or their disease.

If not exposed medical device manufacturers like Avanos pose a threat to the health of patients.

In a number of instances the company exhibited unacceptable behavior, and must be held accountable.

https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/45886049 Avnos Medical Issues a field correction notice about the Cortrak 2 EAS

Avanos is the manufacturer of the Cortrak2 feed tube.

Like surgical gowns and feeding tube placement devices, like the Cortrak 2, are vital in saving lives.

Avanos Medical misbranded the MicroCool surgical dressings, which has raised concerns regarding all medical devices made under the control of the company.

The fears were valid.

Avanos released an official correction request for Cortrak 2 EAS. This could have resulted in injuries or even death.

Ironically, Avanos Medical claims their system can prevent these problems by using screen visualization and location information for tube placement. They are able to verify the placement of their tube using the use of x-rays less frequently.

https://peatix.com/user/15505765 Fox News reported that Avanos confirmed with Fox News that they are currently in an "ongoing discussion" with FDA about the matter.

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

There is need to be cautious with medical devices, such as the Cortrak 2, which has already raised concerns.

It has been proved that Cortrak2 may seriously harm, and even endanger, patient's lives.

Avanos Medical may have made some improvements to the manufacturing process of the product and approval of medical devices, but it's not possible to guarantee safety for patients and other health professionals.

The FDA and the Department of Justice should pay another visit to Avanos Medical's offices to provide comfort to patients and their families.
Here's my website: https://dohabb.com/index.php?page=user&action=pub_profile&id=2592467