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Types of Recalls for Defective Medical Devices

Keeping up-to-date on the types of medical device recalls can be very important for staying safe.

types of medical device recalls


Each year, millions of Americans utilize medical devices for monitoring various medical conditions like eyesight problems, high or low blood glucose levels, irregular heart rhythms or fertility. Some patients use medical devices like pacemakers and defibrillators to help them maintain proper functioning of their vital organs.

So when a device is not working properly or has failed completely, it means that the patient's health and life are in great danger. To protect consumers, the FDA has established mechanisms for manufacturers, distributors and importers to take timely actions in dealing with defective medical devices.

A recall comprises a firm's voluntary correction and removal of a marketed product if the FDA considers it a violation of the FDC&C Act. The FDA is mandated with initiating legal action in such instances. For example, a firm could take a voluntary corrective or removal action upon determining that a device is either misbranded or otherwise adulterated. A misbranded device would include one that contains false information or misleading representation.

Here are the definitions of the nine different levels of recall procedure according to the FDA:

1. Correction

These are actions taken by a firm producing and marketing medical devices to deal with the violative product without physically removing the device to some other location. These actions include modification, repair, relabeling, adjustment or inspection (including patient monitoring).

2. Market Withdrawal

When a firm has removed or corrected a distributed product that is not violative or is not subject to legal action by the FDA, it's said to have done a market withdrawal. In most cases, the product involves no violation at all and is withdrawn for repair, routine equipment adjustments and normal stock rotation practices, among other actions.

3. Routine Servicing

This involves executing the requisite scheduled maintenance of a device. Such action includes promptly replacing parts at the culmination of their normal life expectancy. For instance, the manufacturer or distributor would be required to execute calibration, replace batteries as well as respond to the normal wear and tear. However, routine service doesn't include replacement of multiple units of a device, identical repairs or repairing damages of unexpected nature.

4. Stock Recovery

This involves correcting and removing any device that is yet to get marketed or one that is still under the direct control of the manufacturer. For instance, such a device could still be found on the manufacturer's premises without having been released for use or sale of any portion of the lot, code or model among other relevant units involved in the removal or corrective action.

5. Safety Alert

This recall requires the responsible party to issue a notification to the device users if its use could pose a risk of substantial harm. If, for instance, the use of the device would cause probable adverse health consequences or death, its removal from the market would be considered a recall.

6. Device Enhancement

A device enhancement is directed toward improving the performance or quality of a device. This enhancement is not intended to remedy a violation or any other related regulation that is enforced by the FDA. Conversely, device enhancement is designed to better the experiences of the user. Such changes render it easier to manufacture and change while altering the non-violative performance and safety of the device. They also include changing the general appearance of the device without necessarily affecting its use.

7. Inappropriate Labeling

If a manufacturer or distributor produces a device with labels that are considered false or misleading, or it fails to display adequate directions for proper use, the device could be recalled for inappropriate labeling. Such labels could otherwise violate the FD&C Act regulations, in which case it would get recalled to achieve the applicable labeling requirements. However, adding a new warning (among other modifications) to the labeling of an otherwise non-violative device would not warrant a recall.

8. Non-compliance with FDA Regulations

Every manufacturer or distributor must ensure to conduct themselves carefully. This is achieved through sufficient assessment for each proposed change of their device, and if an incorrect move is taken toward correcting or removing a marketed device to make it comply with the FDA laws, such changes will constitute a medical device recall.

9. Failure to Meet Specifications

Misrepresentation is considered a crime under the FDA rules. If a device fails to meet the represented specification or otherwise doesn't perform as represented and lacks qualities it is purported to possess, then it is considered adulterated under the FD&C Act. Alterations directed towards resolving that failure to meet specifications would generally constitute a recall.

Conclusion of Defective Medical Device Recalls

In any recall action, the recalling firm is tasked with describing the event that resulted in the recall. The responsible party should also state the expected corrective and removal actions that it intends to take as well as the related injuries or illnesses that have since occurred from the use of the device.

If you or a loved one have experienced injury, illness or death due to a defective medical device, you may be entitled to compensation for damages and loss. You will want to contact a personal injury attorney who specializes in product liability law. At Gilreath & Associates, our experienced Tennessee defective medical device lawyers have the knowledge and background needed to represent you. Contact us today to schedule your free consultation.

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