We’ve come a long way in the fields of medicine, science, and healthcare. Doctors and researchers have been able to find cures and paths to wellness for diseases and cancers that have afflicted humans for decades and centuries using tools like medicine, medical devices, and healthcare IT products.
While most of the time these medical products have made a global impact on health and life expectancy, they can occasionally be recalled because they are defective or a risk to someone’s health who is using them.
What happens when a medical product is recalled? How will you know when it happens and what next steps should you take when you hear of a medical product you use being recalled?
WHAT TYPE OF MEDICAL PRODUCT IS IT?
There are various types of medical products, such as medical devices, human drugs, and biological products like blood and blood products. When there is a medical product recall on a medical device, then the product will be regulated by the Food and Drug Administration (FDA) as such. If, however, there is a medical product recall on a human drug, then those are handled by the Center for Drug Evaluation and Research branch of the FDA. Lastly, if there is a medical product recall on blood and blood products, then that is handled by the FDA’s Center for Biologics Evaluation and Research.
For the purposes of this article, we will define a medical product as a medical device, which can range from a simple tongue depressor to a programmable pacemaker.
WHAT IS A MEDICAL DEVICE RECALL?
A medical device recall happens when a manufacturer acts to “correct” or “remove” a product that violates FDA law. These recalls can occur when a device is defective or when it could be a risk to someone’s health (or both).
When a company that makes medical devices learns of a problem with one of their products, they should propose what is called a correction or removal. A correction will address a problem with a medical device in the place where it is sold, and removal will address a problem with a medical device by removing it from where it is sold.
WHAT SHOULD YOU DO IF YOUR PRODUCT IS RECALLED?
The FDA will issue recall information in their Medical Device Recall Database and they will also issue press releases or public notices. When you find out that your medical device has been recalled, you should consult with your doctor, your health insurance company, and an attorney who may be able to sue the medical device manufacturer.
If your medical device was recalled in Georgia, you’re going to need legal experts by your side who understand how to navigate through this complicated process. Don’t go through it alone! Call the Fry Law Team at (404) 948-3571 to set up a consultation today.