FDA Update: June medical device recalls


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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.

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; or 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.

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Medical Devices Recalled in June 2019

DateCompanyDescription of Problem
June 18Cook Incorporated Advance Enforcer 35 Focal Force PTA Balloon Catheter recalled due to balloons bursting below the rated burst pressure.
June 21Teleflex Medical Hudson RCI Sheridan and Sheridan Endotracheal Tubes recalled due to risk of the Sheridan connector separating from the breathing circuit.
June 27Vyaire Medical EnFlow Fluid Warming System Disposable Cartridges recalled due to potential risk of elevated levels of aluminum exposure to patients.
Source: U.S. Food and Drug Administration

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