FDA-Device2013-11-27Class II

Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N

Synovis Surgical Innovations, Inc.
Hazard

Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping

Sold states
Nationwide Distribution.
Affected count
6014 units
Manufactured in
2575 University Ave W, Saint Paul, MN, United States
Products
Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0338-2014

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