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.
What this means for you
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
- Hazard
- mis-labeling
- information-discrepancy
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.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27