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The recall process of a defective medical device

Residents in California and elsewhere use consumer goods for a wide variety of reasons. While automobiles and household items are those frequently encountered, some individuals rely on products every second of the day. Medical devices can provide many health benefits to patients and, in some cases, are the very reason a patient is able to remain at home in a stable condition. While medical devices generate much promise and have success in patients, some are found to be defective. When a medical device has problems or is found to be defective, it must undergo the recall process.

The recall process of a medical device is very specific and is outlined by the FDA. When a company obtains the knowledge that there is a problem with a medical device, they have two courses of action they could take. First, they could take the steps to make a correction. Second, they could remove the product from the market.

A correction is used to address a problem with a medical device at the location where it is used or sold. On the other hand, a removal is used to address the problems associated with a medical device by removing it from the locations where it is used or sold.

When a medical device recall is issued, however, this does not automatically mean that a patient must stop using the product or return it. A recall could simply mean that the medical device needs to be checked, adjusted or fixed. Common examples of actions taken that are considered to be recalls includes inspecting a medical device for problems, repairing the medical device, adjusting the settings on the medical device, re-labeling the device, destroying the device, notifying patients about the problems associated with the device or monitoring patients for potential health issues caused by the defective medical device.

Even when a medical device recall is issued, this does not mean all patients will be informed or that this is timely done to avoid harms to patients. If you have suffered injuries because of a defective medical device, it is important to understand your rights. A products liability suit could help the injured patient hold a company liable while also recovering compensation for losses and damages.

Source: Fda.gov, "What is a Medical Device Recall?," Jan. 3, 2017

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