A Class 1 medical device recall addresses medical devices that reasonably could result in serious injuries or death to consumers. Typically, in the case of Class 1 medical device recall, either the company that manufactured the medical device or the U.S. Food & Drug Administration (FDA) removes the device from the market and notifies consumers of the defect in the device. In this situation, the device violates FDA laws on safety.
This type of recall is the highest level of recall for a medical device by the FDA since it presents a risk of severe harm or death to those patients who use the device. These recalls can be of great concern to patients who use the devices, especially if the device is already implanted in their bodies.
Defining Medical Device Recalls
According to the FDA, a medical device recall occurs when a manufacturer takes action to fix a device that violates FDA safety laws by being defective, a risk to health, or both. The manufacturer may take corrective action or removal action, depending on the circumstances. A corrective action involves the company taking some action to correct or fix the device while it is still on the market and available for use. A removal action takes the product from distributors or retailers that sell the device to repair it or replace it.
A Class 1 medical device recall is more likely to result in removal rather than corrective actions, but that does not always mean that patients have to stop using the device. Sometimes, the company can fix, adjust, or correct the problem without consumers stopping usage of the device or returning it to the company. As a practical matter, these actions may be impossible, such as in the case of a device already implanted in your body. In that situation, you and your doctor may have to determine whether removal or replacement is safe or necessary.
As a result, medical device recalls can cover a wide range of manufacturer actions, from something as simple as relabeling or including additional instructions with a device to the extreme act of destroying the device altogether. A recall may include all the medical devices that a company has manufactured, or only specific lot numbers, models, or lines.
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The Class 1 Medical Device Recall Process
In most cases, the company that developed, manufactured, or distributed the medical device voluntarily recalls the device through corrective action or removal once it becomes aware that it violates FDA safety laws. The company also must notify the FDA about the product recall. Although the FDA has the legal authority to force the recall of a device, such as if a company refuses to recall a product with a risk of serious injury or death, it rarely does so.
Once it receives notice of a recall, the FDA reviews the plan that the company has to recall the medical device. It also measures the risk, determines how it violates FDA laws, and assigns a classification of Class 1, Class 2, or Class 3 to the recall, depending on the severity of the risk to consumers.
In addition to whatever the company does to notify consumers about the medical device recall, the FDA posts information about the recall in its Medical Device Recall Database, which is accessible to the public. The FDA also issues weekly Enforcement Reports that detail medical device recalls. Depending on the seriousness of the risk that the medical device poses, the FDA also may issue press releases or take other actions to inform the public of the risks of using the device.
Get More Information About Legal Claims Involving Medical Device Recalls
Defective medical devices can cause devastating injuries, some of which are fatal to the patients who use them. FDA classification of a medical device recall as a Class 1 recall can serve as critical evidence when you or a loved one has suffered injuries from using a medical device. Fortunately, for you and other victims of dangerous and defective medical devices, manufacturers are liable for the injuries that their devices cause. You may have a legal claim against a manufacturer when you suffer injuries from using a medical device.
When you are already suffering from injuries, worried about medical bills, and unable to engage in your regular activities or work, you may be concerned about the costs of bringing a legal claim against a large medical device manufacturer. We understand that concern at Ben Crump Law, PLLC, and we will pursue your claim with no upfront costs to you. Call (800) 730-1331 and learn more about medical device recalls and what they can mean for your injury claim.