The following product codes are affected by this recall:
1504026 VASCU-GUARD TS 1x6cm
1504028 VASCU-GUARD TS 0.8x8cm
1504030 VASCU-GUARD TS 1x10cm
1504032 VASCU-GUARD TS 2x9cm
UPDATED 06/05/2015. Class I recall notice posted.
AUDIENCE: Cardiology, Nursing, Risk Manager
ISSUE: Baxter International Inc. announced today it is voluntarily recalling four product codes of its Vascu-Guard Peripheral Vascular Patch. Baxter received customer complaints of difficulty in distinguishing the smooth from rough surface of the Vascu-Guard patch as described in the labeled instructions for use. This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism.
BACKGROUND: 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.
RECOMMENDATION: Customers have been directed to locate and remove all affected product from their facilities. Recalled products should be returned 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; it is unaffected by this recall.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178