The U.S. Food and Drug Administration (FDA) is responsible for examining and testing all new medical, cosmetic, and food-related products that will be sold to the American people. In the case of medical devices, these refer to any tool a doctor might use to treat a patient. If the FDA finds a problem with a medical device they think might cause harm to a consumer, they might recall the product. These recalls are separated into three different categories.Class I
A Class I recall is the most serious type and happens if there is a reasonable probability that exposure to a volatile product would cause serious health consequences or death. These tend to be extremely urgent cases and are relatively rare. In these cases, the FDA will also develop an individual plan specific to the manufacturer and the product involved to ensure compliance with the recall is complete. All items in this category should be recalled from the market and from people’s homes. One example of a Class I recall includes St. Jude’s Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators in late 2016.
Class II
A Class II recall happens when there is no immediate danger or death linked to the product; however, the product is still potentially dangerous. These are more preventative in nature but can still cause serious health and safety risks. One example of a Class II devices is the On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single-use, made by CryoLife in 2017.
Class III
These are the least immediate type of device recalls. There is no immediate or perceived danger of any health issues, but items have been released in violation of FDA regulations. An example of a Class III recall includes Optilite IgG4 Kit made by Optilite IgG4 Kit in 2017.
If you were injured by a defective medical device, don’t hesitate to talk to one of our skilled Greenville product liability attorneys. Christian & Christian is dedicated to helping the victims of personal injury seek compensation for their medical bills and lost wages. Let us see what we can do for you.
Contact us at (864) 408-8883 or fill out our online form to schedule a free case consultation today.