Understanding Medical Device and Drug Recalls

 Posted on April 07, 2015 in Arlington Heights Defective Medical Device Attorney

When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.

Recall Classes

The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. A recall is categorized by the FDA as one of the following:

Class III Recall: Exposure to the device or drug is unlikely to result in adverse health consequences, but the product does not meet regulatory standards.

Class II Recall: Exposure to the device or drug may result in “temporary or medically reversible adverse health consequences” or when the likelihood of serious health issues is remote.

Class I Recall: Exposure to the device or drug carries a “reasonable probability” of causing “serious adverse health consequences or death.”

The FDA may also issue “Medical device safety alerts” when a product presents an unacceptable risk of “substantial harm.” These alerts may also be considered recalls in certain cases.

Voluntary and Mandatory Recalls

Manufacturers and distributors of medical devices and drugs are expected to remain responsible for the level of quality and safety of their products, from design through and including consumption and use. When a safety issue is identified, the manufacturer or distributor may issue a voluntary recall. The recall may request that the product in question be returned and professionally repaired or replaced, and, in some cases, may result in a product being removed from the market. The FDA reports that almost all recalls in the United States are considered voluntary.

Mandatory recalls present a more serious situation, in that they often are the result a manufacturer or distributor failing to act on a voluntary basis. The FDA, under its jurisdiction, may issue a recall order to the maker or seller, forcing distribution to be halted and recall procedures to be followed.

The FDA provides guidelines for manufacturers, importers, and distributors to follow regarding the reporting and documentation of both voluntary and mandatory recalls. These rules help the FDA classify and limit possible danger to consumers and oversee the recall process. Failure to comply with the regulatory procedures may result legal action and fines from the administration, to the extent of its federal authority.

Defective Product and Drug Attorneys

If you have been injured or suffered adverse health consequences due to any type of defective medical device or commercially available drug, you may have options available to you. Contact an experienced Arlington Heights personal injury attorney today to discuss your case, and let us help you pursue the compensation you deserve.