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Cortrak Medsystems Cortrak 2 device.
11 patients were among the 51 MDRs who died because of the misuse of Cortrak 2.
Avanos Medical feeding tube Fox News just recently reported that Avanos Health had issued an error-correction notice for its Cortrak2EAS due to possible fatal results.
This tragic event highlights the grave dangers of the feeding tube industry and its impact on the lives of people.
The Food and Drug Administration could be investigated.
It's not the first time that they've had to mess with the FDA - Avanos Medical had a Criminal Indictment against it for Fraudulent Misbranding
The impact of medical devices human lives is what makes it one of the most highly regulated industries worldwide.
Despite all the regulations, there are still some alarming cases in the business.
Although it might not sound like an issue however, the name Avanos Med might. However, if the news is related to the medical device industry you might have heard about an interesting instance.
Avanos sold thousands of MicroCool surgical gowns between November 2014 and January 2015.
Cortrak 2 eternal access system They claimed that the MicroCool surgical gowns could guard against fluid and virus penetration and meet FDA's most stringent standards. However, this claim was false as the surgical gowns failed tests for penetration of viruses and the company was modifying the methods employed to seal the gowns.
All this was revealed in July 2016 when the FDA examined Avanos"surgeon's gown business.
They discovered that an employee had falsified company papers in order to be deceived by FDA.
Avanos Medical feeding tube These poor-quality devices resulted in hundreds of injuries.
Avanos should have known that MicroCool's surgical gowns were not the safest against infection by viruses. They claimed that they were and falsified documents.
Avanos Medical feeding tube Remember that the medical industry is a delicate field. Who knows how many people were killed due to their actions?
Demand further investigation into Avanos Medical
Avanos Medical paid $22 million in July 2021 as part of the Data Processing Agreement. This was to resolve the felony charge.
Avanos and the Department of Justice reached a agreement on deferred prosecution in relation to violations that are criminally committing Federal Food, Drug & Cosmetic Acts (FDCA).
Avanos continues to face issues with its products.
They were repeatedly cited several times by the FDA as well as by the DOJ for criminal activity related to the products. Despite all the efforts, many people still be unhappy with the products of the company.
Patients must feel secure when using medical devices. In order to not be concerned about what could kill them, the medical device or even their illness.
Avanos, the medical device manufacturer poses a danger to the safety of patients in the event that they are not exposed.
In a number of instances the company has displayed unacceptable behavior, and must be held accountable.
Avnos Medical Issues, a field correction notice regarding the Cortrak 2 EAS
Avanos medical, as previously stated, is responsible for the production of the Cortrak 2 feeding tube.
Similar to surgical gowns, but equipped with feeding tubes, devices such as the Cortrak 2 that place feeding tubes are crucial in saving lives.
Avanos Medical's misbranding case of MicroCool surgical dresses has caused worry about all medical equipment produced by the company.
And indeed the concerns were valid.
Avanos has, as previously reported had released a correction field for the Cortrak 2 EAS. That could have caused the death of a person, injury or both.
It's ironic that Avanos Medical claims that their system avoids such issues by using location information and visualizing the screen during tube's placement. It doesn't require confirmation by x-ray.
Avanos confirmed that with Fox News they are in an "ongoing dialogue" with the FDA on the matter.
They said they "cannot comment" and added that the FDA has not asked to conduct a product recall.
You must exercise care when using medical equipment such as Cortrak 2, that have already raised questions.
It has been demonstrated that Cortrak2 can cause serious injuries to and even kill patients.
Despite the modifications which Avanos Medical claims to make in their production process and medical device approval systems, patients and health professionals can never be sure that these products are safe.
Avanos Medical The FDA and the Department of Justice should pay another visit to the Avanos Medical offices to reassure the patients and their families.
Website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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