Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues
Synovis is recalling Vascu Guard and Dura-Guard patches because specific fluid ounce units shipped in divided cell configurations with a specific revision of the Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a shipping configuration issue without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving potential but unreported harm.
Plain-English summary
Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of Vascu Guard and Dura-Guard. These products are peripheral vascular patches used for peripheral vascular reconstruction. The recall involves 6,014 units distributed nationwide.
The recall was initiated because the shipping configurations for 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) were shipped in a divided cell shipping configuration. The source text does not specify the exact nature of the defect or the potential clinical consequences of this shipping error.
Healthcare providers and patients who have received these specific lots of Vascu Guard or Dura-Guard should contact Synovis Surgical Innovations, Inc. for further instructions on how to handle the affected units. The recall number is Z-0338-2014.
The recalled product
- Product
- 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…
- Manufacturer
- Synovis Surgical Innovations, Inc.
- Category
- Medical Device — Vascular Patch
- Affected units
- 6,014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Synovis Surgical Innovations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Synovis Surgical Innovations, Inc.
See all →- SevereSynovis Recalls Vascu-Guard Patches Due to Surface Identification Issues
FDA (Devices) · 2015-06-10
- ModerateSynovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors
FDA (Devices) · 2013-11-27
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