Notes

Cortrak 2 EAS from Avanos Medical Increases Patient Safety
Cortrak Medsystems Cortrak 2 device.

11 MDRs out of 51 were killed as a result of misusing the Cortrak 2 unit.

Avanos Medical feeding tube Fox News just recently reported that Avanos Health had released an update to the Field Correction Notice for Cortrak2EAS due to possible fatal results.

This incident highlights the risks of the feed tube industry and the effects it has on the lives of individuals.

The news could trigger an investigation by the Food and Drug Administration (FDA) investigation.

Cortrak 2 eternal access system Not the first time messing with the FDA - Avanos Medical had a Criminal charge brought against it for fraud. Misbranding
Because of its effect on human life, the medical device industry is one of the most rigorously controlled industries in the world.

Despite the strict rules there are still a few worrying instances.

Although the name "Avanos Medical" might not sound familiar If you're an avid follower of medical device industry news you've probably heard about a case that involved the company.

Avanos has sold hundreds of MicroCool Sacrificial gowns during the period November 2014-January 2015.

According to them they claimed that the MicroCool surgical gowns met the strictest standards that was set by the FDA and could effectively protect against virus and fluid penetration. However, this is false since the surgical gowns failed the virus penetration tests. Additionally the company was altering the sealing method used to seal the gowns.

This information was discovered in the month of July by the FDA when it investigated Avanoscompany that sells surgical gowns.

The company's documents were falsified made by an employee of the company in order to deceive the FDA.

Avanos Medical feeding tube The devices were not well-designed and defectively created, resulting in the deaths of hundreds of people.

So if Avanos realized they were not able to prove that their MicroCool surgical gowns did not offer the greatest protection against the penetration of viruses and fluids So why did they put forward the claim? And did they fake documents?

Be aware that the medical field is extremely delicate. https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ And who can tell how many patients died due to their conduct?

Avanos Medical is available for consultation
Avanos Medical, in July 2021, agreed to pay $22,000,000 in a Data Processing Agreement. (DPA). The agreement was made to end this felony count.

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' products have caused problems for many years.

They were repeatedly cited multiple times by FDA and the DOJ for criminal activity related to the products. Despite all the efforts made by the agencies, there are many who have issues with the company’s products.

Patients must feel secure when making use of medical devices. Therefore, they do not have to worry about who will end their lives first, the medical devices or their illness.

If they are not exposed medical device companies such as Avanos pose a threat to the safety of patients.

The company has been accused of criminal behavior in numerous instances. They must be held accountable.

Avnos Medical Issues A field correction notification with regard to the Cortrak 2 EAS

Avanos medical, as mentioned, is the company responsible for the production of the Cortrak 2 feeding tube.

Like surgical gowns but with feeding tubes, equipment such as the Cortrak 2 that place feeding tubes are essential to save lives.

The issue of the false branding of MicroCool surgical gowns by Avanos Medical has raised cause for concern about all medical devices manufactured by the company.

These concerns are indeed valid.

As previously mentioned, Avanos released a voluntary field correction for the vital Cortrak 2 EAS, that could have caused injuries or even death.

Incredibly, Avanos Medical claims that its system will eliminate these issues by using screen visualization and location data during tube placement. They are able to verify the placement of their tube using x-rays less often.

Fox News reported that Avanos confirmed via Fox News that they are currently engaged in an "ongoing discussion" with FDA concerning the matter.

They claimed they were unable to make a statement, and that the FDA hasn't asked them to recall any of their products.

Avanos Medical feeding tube There is a need to be cautious with medical devices, such as Cortrak 2. Cortrak 2, which has been a source of concern for a while.

It has been proved that Cortrak2 can seriously injure or even threaten patient's lives.

Despite the modifications which Avanos Medical claims to make changes to their manufacturing and medical device approval systems, patients and health professionals can never be sure how safe these products are.

Avanos Medical feeding tube The FDA and the Department of Justice should pay another visit to the offices of Avanos Medical to reassure the patients and their families.
Here's my website: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/