Flaw in Peripheral Vascular Patch Packaging Configuration Increases Risk of Blood Vessel Thrombosis or Embolism

Baxter International Inc. has voluntarily recalled four product codes of its Vascu-Guard Peripheral Vascular Patch after receiving complaints from customers who have had difficulty distinguishing the smooth from rough surface of the Vascu-Guard patch as described in the labeled instructions for use.

According to a U.S. Food and Drug Administration (FDA) safety alert posted on the agency’s website, the problem is a result of a deviation in the surface texture of the vascular patch in a new packaging configuration. There is an increased risk of vessel thrombosis and/or embolism if a customer places the patch with the rough side facing toward the blood stream. The Vascu-Guard Peripheral Vascular Patch is intended for use in peripheral vascular reconstruction including carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions.

Customers should locate and remove all affected product from their facilities and return them to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001. Customers can still order this product presented in a plastic jar filled with sterile water and 1% Propylene Oxide, which is unaffected by the recall.

Consumers with questions about this recall can contact Baxter at 1-800-422-9837. Customers should contact their doctor or health care provider if they experience any adverse events as a result of using one of the recalled Vascu-Guard Peripheral Vascular Patches.

The post Flaw in Peripheral Vascular Patch Packaging Configuration Increases Risk of Blood Vessel Thrombosis or Embolism appeared first on Parker Waichman -

from Parker Waichman http://www.yourlawyer.com/blog/flaw-in-peripheral-vascular-patch-packaging-configuration-increases-risk-of-blood-vessel-thrombosis-or-embolism/