Sunday, February 23, 2020

Sunday, February 23, 2020

FDA Update: September medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration (FDA).

Recalls, which are usually initiated by companies but can also be ordered by the FDA, take place when a device has defects or when it poses dangers to human health, the FDA's website says. The FDA reviews how companies plan to deal with problems with their devices and can assign a classification of risk to a problem raised by the manufacturer. 

The FDA can assign one of three classifications: Class 1, referring to a reasonable chance of serious health threats or death; Class II, when a temporary health condition can result, or when there is a small risk of serious injury or death; and Class III, when no health problem or injury is likely.

The agency posts notifications about recalls on its Medical Device Recall Database and may also post company press releases or announcements to warn consumers about such problems.

Medical Devices Recalled in September 2019

DateCompanyDescription of Problem
Sept. 12AllerganNatrelle Biocell Textured Breast Implants Recalled Due to Risk of Breast-Implant-Associated Anaplastic Large-Cell Lymphoma, or BIA-ALCL
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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