Notes

Cortrak 2 EAS by Avanos Medical Increases Patient Safety
Cortrak 2 from Avanos Medical - can the patients feel secure? feeding tube placement New Report could reveal the solution

Avanos Medical, one of the Cortrak 2 Enteral Access System manufacturers (EAS), is also known as Avanos Medical.

Cortrak 2 devices are used in medical settings to set up feeding tubes.

Between January 2012 to July 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the Cortrak Medsystems Cortrak 2 device.

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

Recently, Fox News revealed that Avanos Medical issued an error-in-field notice regarding its Cortrak 2 EAS due to potential deadly outcomes.

https://list.ly/humphreyhansson704 This case illustrates the serious risks of this industry as well as its effect on people's health.

The revelation might lead to the Food and Drug Administration (FDA) investigation.

Avanos Medical was charged with fraudulent misbranding and it is not the first time they've misbehaved with FDA
Due to its effects on human health medical devices are among of the most heavily regulated sectors around the globe.

There are, however, worrying cases in the industry despite these regulations.

While the title "Avanos Medical" may not be familiar but if you're a follower of the medical device industry, you may have read about a controversy with this company.

Avanos sold hundreds and thousands of MicroCool surgical gowns from November 2014 until January 2015.

They claimed that the MicroCool surgical gowns were able to guard against fluid and virus penetration and met the FDA's most stringent standards. But, this assertion was false as the surgical gowns failed viral penetration tests and the company was modifying the sealing methods employed to seal the gowns.

Avanos Medical feeding tube All this information was discovered in the month of July by the FDA when it investigated Avanosthe business that sold surgical gowns.

feeding tube placement The FDA was deceived by false company documents that were created by an employee of the firm.

These devices were poorly designed and defectively created, resulting in accidents to hundreds of people.

If Avanos knew that their MicroCool surgical gowns did not provide the best protection against virus and fluid penetration Why did they make the claim? And did they lie on documents?

Keep in mind that the medical field is not a safe profession. Who knows how many lives were affected by their work.

Avanos Medical is available for consultation
Avanos Medical arranged to pay $22 Million under a Data Processing Agreement.

Avanos signed a deferred prosecution agreement with the Department of Justice regarding criminal violations of the Federal Food, Drug & Cosmetic Act (FDCA).

Avanos continues to face issues with their products.

Several times they have been penalized by the FDA and the DOJ for criminal acts connected to their goods. Despite the agencies efforts, there are people still experiencing issues with the products of the company.

Patients should feel secure using medical devices. To ensure that they do not have to worry about what might kill them, the medical device, or the illness they suffer from.

Avanos as well as other medical device makers, pose a threat for patients' safety.

The company has been accused of the same criminal behavior in multiple instances and must be held accountable for its actions.

Avnos Medic Issues Field Correction Note concerning the Cortrak 2 EAS

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

Similar to surgical gowns but with feeding tubes, devices such as the Cortrak 2 that place feeding tubes are vital to saving lives.

The misbranding of Avanos Medical's case of MicroCool surgical gowns has raised worry about all medical equipment produced by the company.

The fears were valid.

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

Incredibly, Avanos Medical claims that its system eliminates such issues through screen visualization and location data in the process of tube placement. So, they'll require less the confirmation of x-rays.

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

Cortrak 2 eternal access system They claimed that they were "unable to provide a comment" and stated that the FDA did not ask for a recall.

There is need to be aware with medical devices such as Cortrak 2. Cortrak 2, which has already raised questions.

It's been proven that Cortrak2 may seriously harm and even risk the lives of patients.

Avanos Medical claims that they have improved the manufacturing of medical device approval systems. But, it's difficult for health professionals to be sure about how safe these products actually are.

The offices of Avanos Medical should be checked out by the FDA and Department of Justice. This can help reassure patients as well their families.
Here's my website: http://www.drugoffice.gov.hk/gb/unigb/www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its