FDA Announces Recall of Peripheral Vascular Patch

The U.S. Food and Drug Administration (FDA) announced on June 3 that Baxter International Inc. voluntarily recalled four product codes of the Vascu-Guard Peripheral Vascular Patch, used in peripheral vascular reconstruction. The company reports that customers had difficulty differentiating the smooth and rough surfaces of the patch as directed in the product instructions. Improper placement of the rough side of the patch toward the bloodstream “may increase the risk of vessel thrombosis and/or embolism,” according to the FDA’s announcement

Keywords: Embolism, Product Recalls and Withdrawals, Thrombosis, United States Food and Drug Administration

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