Understanding different classifications of FDA recalls for defective medical devices
Manufacturers and distributors of medical devices have a responsibility to protect the health and well-being of the public. When products fail to meet the safety standards established by the Food and Drug Administration (FDA), a recall warning should be issued to initiate the recall process.
What is a recall?
A recall is a process for removing or correcting a product that is in violation of FDA safety standards. The recall process provides manufacturers and distributors with a standardized procedure to help protect the public “from products that present a risk of injury or gross deception or are otherwise defective.”
Medical device recalls are typically voluntary and replace any FDA-initiated court actions against the offending companies. On rare occasions, the FDA may issue a mandatory device recall if the manufacturer or distributor fails to do so voluntarily, or if the product poses a serious threat to public health and safety.
What are the different types of medical device recalls?
The FDA classifies devices that are being recalled into three distinct categories:
- Class I – Highly probable that use or exposure to the defective device will cause severe or fatal injuries.
- Class II – Use or exposure to the defective device may cause temporary or medically-reversible health issues.
- Class III – Use or exposure to the defective device is not likely to result in adverse health-related consequences.
Recall remedies vary depending on the specific product and defect, but consist of either correction or removal actions. Corrections attempt to repair, modify, adjust, destroy or inspect a device without it being physically removed for a specific location.
Removals require a device be moved or returned to another location for repairs, modifications, adjustments, destruction or inspection.
What is the recall procedure for a defective medical device?
When a manufacturer or distributor wishes to initiate a product recall, they should immediately notify the appropriate FDA District Office. In this notification, the recalling firm should identify the product and its defect, supply estimated quantity and distribution information, and propose a recall strategy.
The FDA will review all information submitted with the notification, evaluate the product’s health hazards, provide a recall classification for the product and supply any revision to the firm’s strategy for the product recall.
From that point on, it is the reporting firm’s responsibility to notify all affected parties of the recall. Typically, this is done through a letter that identifies the defective product, explains the nature of the defect and provides instruction regarding what to do next.
The company also must provide the FDA with status reports every two to four weeks. The recall continues until the FDA determines all reasonable efforts were made to remove or correct the product and issues written notice that the recall is terminated.
In addition to direct notifications, a weekly FDA Enforcement Report includes a list of all active recalls. This list is published on their website: www.fda.gov/medicaldevices/safety/default.htm
When to contact a defective medical device injury lawyer?
Unfortunately, not every patient injury is prevented by medical device recalls. When an individual is harmed by a defective medical device, he or she may be entitled to legal recourse. If you are in this situation, consider meeting with a personal injury attorney who specializes in defective medical devices and product liability law to discuss your options.
