Notes

Cortrak 2 EAS of Avanos Medical Raising Safety of Patients
Cortrak Medsystems Cortrak 2 device.

11 MDRs of the 51 who died as a result of misusing the Cortrak 2 unit.

Fox News just recently reported that Avanos Health had released an error-correction notice for Cortrak2EAS due to the possibility of deadly consequences.

This event shows the significant dangers associated with the feeding tube industry as well as its effects on people's lives.

The Food and Drug Administration might be investigating the revelation.

Avanos Medical was also charged criminally for fraud in brand name misbranding.
Because of its direct impact on the lives of people, the medical devices industry is one of the most closely regulated.

Despite the strict regulations there are still a few alarming instances.

While the name "Avanos" may not sound very appealing, if your interest is in the field of medical devices you may have come across a case about this firm.

Avanos sold hundreds of MicroCool surgical gowns between November 2014 and January 2015.

According to MicroCool's website, the surgical gowns meet the FDA's most stringent standards of protection against viruses and fluids. But, this assertion was not true as the surgical gowns failed tests of penetration by viruses and the company was changing the sealing methods used to seal the gowns.

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

Cortrak 2 eternal access system The FDA was deceived by false documents for the company that were made by an employee of the company.

These defective devices caused injuries to hundreds of people.

So if Avanos realized that their MicroCool surgical gowns do not provide the best protection against fluid and virus penetration, why did they make the claim? And did they fake documents?

Remember that the medical field can be a delicate one and many have lost their lives due to their actions.

Avanos Medical is available for consultation
In the month of July 2021, Avanos Medical agreed to pay $22 million in the context of a Data Processing Agreement (DPA) to end this felony.

Avanos signed a Deferred Prosecution agreement with the Department of Justice in relation to criminal violations of Federal Food, Drug & Cosmetic Act.

As of now, Avanos has repeatedly had problems with its products.

Avanos Medical They were repeatedly cited several times by FDA as well as the DOJ for criminal activity connected to their products. Cortrak 2 eternal access system Despite all the efforts of the agencies, there are many who have issues with their products.

Patients should feel comfortable using medical devices. Patients needn't worry about what medical device is going to be the first to kill them.

Avanos as well as other medical device companies pose a threat to patient safety if not exposed.

The company has been accused of pattern of criminal conduct in several cases and needs to be held responsible for its conduct.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avnos Medical Issues A field correction notification concerning the Cortrak 2 EAS

Avanos Medical is responsible for the production of Cortrak 2's feeding tube.

Cortrak 2 eternal access system Avanos Medical Similar to surgical gowns but with feeding tubes, devices like the Cortrak 2 that place feeding tubes are vital to saving lives.

The case regarding the false branding of MicroCool surgical gowns by Avanos Medical has raised cause for concern regarding the medical devices made by the company.

These issues were legitimate.

Avanos provided a voluntary field correction for Cortrak 2 EAS. Unfortunately it could have led to injuryor death.

The irony is the fact that Avanos Medical claims that their system avoids such issues through the use of location information and screen visualization during a tube's positioning. They don't require x-ray confirmation.

Avanos confirmed that with Fox News they are in an "ongoing dialogue" with the FDA regarding the issue.

They stated that they were unable to comment, and added that the FDA had not asked to recall any product.

It is crucial to exercise extreme caution when using medical devices, like the Cortrak 2 which have raised concerns.

It has been proven that Cortrak 2 may severely harm or even threaten patients' lives.

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

Avanos Medical feeding tube Avanos Medical should be visited again by the FDA and Department of Justice to provide peace to patients and their families.
Homepage: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its