Baxter PERI-GUARD SUPPLE marketing brochure contains inaccurate instructions
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual 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 a Class II recall involving a documentation/labeling issue where marketing materials contain inaccurate content conflicting with official instructions for use. No illnesses or injuries have been reported, and the hazard is one of potential misuse due to information mismatch rather than an inherent product defect.
Plain-English summary
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices that were distributed nationwide. The recall involves multiple product sizes and variants, identified by specific product codes and UDI numbers.
The reason for the recall is that a cardiovascular surgery marketing brochure distributed for these products contains inaccurate content that does not align with the products' Instructions for Use (IFU) or Prescribing Information (PI).
Healthcare providers and users should use the official Instructions for Use or Prescribing Information provided with the device rather than relying on marketing materials. Contact Baxter Healthcare Corporation with any questions or concerns about these products.
The recalled product
- Product
- PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM…
- 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 (9)
- a) SPG1016: UDI/DI 85412818429
- b) SPG0404: UDI/DI 85412818672
- c) SPG0608: UDI/DI 85412818313
- d) SPG0814: UDI/DI 85412818375
- e) PC1016SNBIO: UDI/DI 85412530710
- f) PC0404SNBIO: UDI/DI 85412530642
- g) PC0608SNBIO: UDI/DI 85412530673
- h) PC0814SNBIO: UDI/DI 85412530697
- 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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