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What does a medical device recall look like?

As a previous post noted, medical devices are often a necessary product in the lives of Louisiana residents. Although these items serve a vital role, some problems can arise. A malfunction could occur, causing a defective medical device. While this situation could result in little to no harm to the patient using the medical devise, a malfunction could generate a dangerous product that could cause serious injury or even death. Thus, a recall is usually issued in these situations.

What does a medical device recall look like? There are two steps that could be taken when a company learns that there are problems with a certain medical devices. First, a correction could be made. This means that the problems with the medical device areaddressed. This typically occurs in the place where they were sold or placed.

The second action that could be taken is removal. This addresses the problems presented by the medical device by removing it from the market as well as from the patients that are using them. According to the FDA, when a medical device violates FDA law and a manufacturer takes action to correct it or remove it, this is considered a recall.

When a recall is issued, this does not always mean that a patient must stop using the device or return it to the company. Other actions align with a recall, which includes inspecting the device for problems, repairing the device, adjusting the setting on the device, re-labeling the device, destroying the medical device, notifying the patient about the problems with the device and monitoring a patient for health issues.

No matter what action is taken, it is important that patients are aware when a medical device recall occurs. Even more so, if a defective device that was not properly recalled harms a patient, it is possible to seek damages for the pain and suffering resulting. A products liability claim could help a patient recover compensation for their losses.

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

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