The FDA issues a Class I recall for Vascu-Guard Peripheral Vascular Patch by Baxter

Patient Safety Monitor Insider

June 17, 2015

On June 5th, the FDA posted a Class I recall notice for the Vascu-Guard Peripheral Vascular Patch. The manufacturer, Baxter International Inc., announced a voluntary recall after receiving complaints of difficulty in distinguishing the smooth from the rough surface of the Vascu-Guard patch as described in the labeled instructions. If the patch is applied incorrectly with the rough side toward the bloodstream, there is a possible increase in the risk of vessel thrombosis and/or embolism.

Customers should remove all affected product and return it to Baxter. Note that the product presented in a plastic jar filled with sterile water and 1% Propylene Oxide is not included in this recall.

For further information on this recall visit the FDA website here.