Peri-Guard Repair Patch marketing brochure contains inaccurate information
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's 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: This is an FDA Class II recall involving a documentation and labeling discrepancy between marketing materials and official Instructions for Use/Prescribing Information. No illnesses, injuries, or deaths have been reported, and the issue is informational rather than a product defect.
Plain-English summary
Baxter Healthcare Corporation is recalling a cardiovascular surgery marketing brochure (US-AS46-220001) distributed for Peri-Guard Repair Patch products in multiple sizes: PG1016 (10 x 16), PG1225 (12 x 25), PG0404 (4 x 4), PG0608 (6 x 8), and PG0814 (8 x 14). The brochure contains inaccurate content that does not align with the Instructions for Use (IFU) or Prescribing Information (PI) for some of the products.
The discrepancy between marketing materials and official product documentation could affect proper use or understanding of indications. Healthcare providers and facilities nationwide who have received this brochure should refer to the official Instructions for Use and Prescribing Information for accurate product guidance rather than relying on the marketing materials.
The affected products were distributed nationwide. Users of these products should contact Baxter Healthcare Corporation for corrected information.
The recalled product
- Product
- Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS
- Manufacturer
- Baxter Healthcare Corporation
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 (6)
- a) PG1016: UDI/DI 85412818610
- b) PG1225: UDI/DI 85412818658
- c) PG0404: UDI/DI 85412818405
- d) PG0608: UDI/DI 85412818443
- e) PG0814: UDI/DI 85412818597
- 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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