Cortrak 2 EAS from Avanos Medical raises Safety of Patients
Cortrak Medsystems Cortrak 2 device.
11 patients from the MDRs 51 were killed due to misuse of Cortrak 2 devices.
Avanos Mediacal Cortrak 2 Fox News reported that Avanos Medicine published an update announcement regarding Cortrak 2 EAS. The notice was released in response to the possibility of fatalities.
This highlights the serious risks of feeding tubes as well as their impact on human life.
This could lead to an investigation being conducted by Food and Drug Administration.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos Medical was not the only one to play with the FDA. A criminal charge was brought against the company for fraudulent false branding.
The industry of medical devices is among the most tightly controlled sectors in the world because of its impact on the lives of humans.
Despite the strict rules there are still a few troubling instances.
The name 'Avanos medical' may not ring a alarm, but if you read the news about the medical devices industry you may have heard of a case concerning this company.
Avanos sold hundreds of thousands of MicroCool surgical clothes that were misbranded between November 2014 and January 2015.
According to them they claimed that they claimed that the MicroCool surgical gowns met the standards that was set by the FDA and were able to effectively guard against virus and fluid penetration. But, this assertion was not true as the surgical gowns failed viral penetration tests and the company was altering the method employed to seal the gowns.
They were all discovered after FDA investigators looked into Avanos' business in surgical gowns.
To fool FDA to deceive FDA, they discovered falsified documents issued by the company.
The devices' design flaws caused injuries to hundreds.
Avanos should have been aware that the MicroCool gowns they created for use in surgery didn't offer the best protection against fluid and virus penetration. So why did they say this?
Medical professionals are delicate and numerous lives have been lost because of their actions.
Contact Avanos Medical for more information
Avanos Medical made a $22 million payment as part a Data Processing Agreement.
Avanos signed an agreement for deferred prosecution (DPA) with the Department of Justice for criminal violations of Federal Food, Drug & Cosmetic Act.
At this point, Avanos has repeatedly had problems with their products.
The FDA and DOJ have issued citations to them numerous times for crimes related to their products. Despite all these efforts, consumers continue to complain about the company's products.
Patients need to feel at ease when using medical equipment. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical In order to not think about what could harm them, the medical device, or even their illness.
Avanos as well as other medical device makers are a risk to the safety of patients.
In a number of instances the company exhibited unacceptable behavior, and must be held responsible.
Avanos Medical feeding tube Avnos Health Issues is a correction to the field announcement regarding the Cortrak 2 EAS
Avanos medical produces the Cortrak2 feeding tube.
Similar to surgical gowns but with feeding tubes, devices like the Cortrak 2 that place feeding tubes are crucial in saving lives.
Avanos Medical is suing to make a mistake with the MicroCool surgical dress. The lawsuit has raised questions regarding all medical products made by Avanos Medical.
The concerns were valid.
As stated before, Avanos released a voluntary field correction for the vital Cortrak 2 EAS, that could have caused injury or even death.
It's ironic that Avanos Medical claims its system will prevent such issues by using screen visualization and location information in the process of tube placement. They are able to verify their tube placement with the use of x-rays less frequently.
Fox News reported that Avanos confirmed with Fox News that they are currently engaged in an "ongoing discussion" with FDA regarding the issue.
They said they "cannot comment" regarding the issue and added that the FDA hasn't requested to recall products.
When using medical devices such as Cortrak 2, Cortrak 2, which have already raised cause for concern it is imperative for great caution.
It has been shown that Cortrak 2 can seriously harm and put an end to the lives of patients.
Avanos Medical claims they have improved their manufacturing and approval processes, but healthcare professionals and patients are not able to know how safe these devices are.
The offices of Avanos Medical should be visited again by both the FDA as well as the Department of Justice. This will help to reassure patients as well their families.