Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0339-2014·Announced 2013-11-27

Synovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors

Synovis is recalling Dura-Guard and Vascu-Guard patches because specific units were 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, but the source text describes a shipping configuration issue without reporting any injuries, illnesses, or specific clinical hazards. This aligns with the rubric for moderate severity involving minor labeling or packaging/shipping issues without reported harm.

Plain-English summary

Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of Vascu-Guard and Dura-Guard products. The recall involves 446 units of Dura-Guard, Dural Repair Patch with Apex Processing, which is used as a dura substitute for the closure of dura mater during neurosurgery. The affected product codes include DG0209SN, DG0404SN, and DG0608SN.

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.

The affected units were distributed nationwide. Specific lot numbers are listed in the recall documentation, including SPCE113-03C0006, SPCE113-04D0002, and others. Healthcare providers and facilities should check their inventory for these specific lot numbers and product codes. Consumers are not directly affected as this is a medical device used in surgical settings.

The recalled product

Product: Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN…
Manufacturer: Synovis Surgical Innovations, Inc.
Category: Medical Device — Neurosurgical Dura Substitute
Hazard: shipping-error
if-revision
Affected units: 446

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 →

Same manufacturer · Synovis Surgical Innovations, Inc.

See all →

Severe
Synovis Recalls Vascu-Guard Patches Due to Surface Identification Issues
FDA (Devices) · 2015-06-10
Moderate
Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues
FDA (Devices) · 2013-11-27

Same hazard · shipping error