Cardiovascular Surgical Patch Marketing Brochure Contains Inaccurate Information
Baxter is recalling marketing materials for Vascu-Guard Peripheral Vascular Patch because a brochure contains inaccurate information that conflicts with the product's official instructions and prescribing information.
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: FDA Class II recall with no reported injuries or illnesses. The issue involves marketing brochure content that conflicts with official Instructions for Use and Prescribing Information—a labeling discrepancy without documented harm.
Plain-English summary
Baxter Healthcare Corporation is recalling its Cardiovascular Surgery marketing brochure (US-AS46-220001) for the Vascu-Guard Peripheral Vascular Patch. The recall affects four product sizes: VG0108 (0.8 X 8 CM), VG0110 (1 X 10 CM), VG0106 (1 X 6 CM), and VG0209 (2 X 9 CM).
The marketing brochure contains inaccurate content that does not align with the product's official Instructions for Use (IFU) and Prescribing Information (PI). This misalignment could potentially lead to confusion or improper use of the surgical device.
The Vascu-Guard Peripheral Vascular Patch has been distributed nationwide throughout the United States. Healthcare providers should refer to the official Instructions for Use and Prescribing Information for accurate product guidance.
The recalled product
- Product
- Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- a) VG0108: UDI/DI 0338-9564-06
- b) VG0110: UDI/DI 0338-9564-07
- c) VG0106: UDI/DI 0338-9564-08
- d) VG0209: UDI/DI 0338-9564-09
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Baxter Healthcare Corporation 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.
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