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How medical device recalls work to protect consumers

Kentucky residents who rely on medical devices may be interested in reading about the how a recall of those devices works and what their options include. First, whenever a medical device becomes hazardous to health, defective or both, the responsible party must issue a recall of the product in keeping compliant with Food and Drug Administration regulations. A recall does not necessarily mean that a consumer is no longer able to use the product, but the product may need to be adjusted. For example, if a pacemaker has been recalled due to a potential sudden failure, the manufacturer usually alerts doctors to communicate with their patients about the risks involved in keeping it in place versus taking it out.

Recalls involve repairing, inspecting, destroying or re-labeling the medical device in question. A recall may also involve monitoring the patients who are using the device for any health concerns. Sometimes, the manufacturer may recall a large number of its products because it is not able to pinpoint the one in question. Therefore, the recall may include an entire product line, a complete lot or the product's model.

Moreover, there are two types of recalls: removal and correction. In a removal, the manufacturer will completely remove the problematic device from where it is sold or used. In a correction, the manufacturer will simply have the problematic device corrected at the place where it is being sold or used.

In instances where a consumer is injured from dangerous or defective medical equipment, he or she may wish to retain the services of a local product liability attorney. After analyzing the case, the attorney may be able to advise the client of his or her eligibility in pursuing compensation for damages by holding the company liable.

Source: U.S. Food and Drug Administration, "What is a Medical Device Recall?", October 20, 2014

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