Peri-Guard Repair Patch Recall Due to Inaccurate Marketing Brochure
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with 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: FDA Class II recall with no reported illnesses or injuries. The hazard is inaccurate marketing information rather than a defect in the product itself. The actual Instructions for Use and Prescribing Information remain accurate.
Plain-English summary
Baxter Healthcare Corporation is recalling Peri-Guard Repair Patch products (multiple sizes: 4x4, 6x8, 8x14, 10x16, and 12x25 inches) distributed nationwide in the United States.
A cardiovascular surgery marketing brochure distributed for these products contains inaccurate information that does not match the product's Instructions for Use (IFU) or Prescribing Information (PI). Healthcare providers and facilities using these products should not rely on the marketing brochure for accurate product information.
Users should review and follow the official Instructions for Use and Prescribing Information provided with the product rather than the inaccurate marketing materials. Contact Baxter Healthcare Corporation for clarification or if you have questions about proper product use.
The recalled product
- Product
- Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Surgical patch
- 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) PC1016NBIO: UDI/DI 85412530604
- b) PC1225NBIO: UDI/DI 85412530628
- c) PC0404NBIO: UDI/DI 85412530529
- d) PC0608NBIO: UDI/DI 85412530567
- e) PC0814NBIO: UDI/DI 85412530581 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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