FDA Issues Recall of Pleural and Pneumopericardial Drainage Sets
The U.S. Food and Drug Administration (FDA) has issued a class I recall of Stryker Fuhrman’s pleural and pneumopericardial drainage sets as the catheter may break during insertion. In two instances, medical intervention was needed after the catheter broke in the pleural cavity during insertion. Such an event could result in serious injury or death in the patient.
According to the FDA, use of the product should be discontinued and all affected devices should be returned to Stryker Fuhrman.
Keywords: Catheters, Pleural Cavity, United States Food and Drug Administration
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