FDA-Device2015-06-10Class I
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and t
Synovis Surgical Innovations, Inc.
Hazard
Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
Sold states
Nationwide Distribution.
Affected count
3,974
Manufactured in
2575 University Ave W, N/A, Saint Paul, MN, United States
Products
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2015Don't want to check this manually?
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