Baxter FloSeal Hemostatic Matrix brochure contains inaccurate clinical information
A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use 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: This Class II recall involves informational discrepancies in marketing materials with no adverse events or injuries reported. Per the severity rubric, labeling errors in medical devices without reported harm warrant a Moderate severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling a cardiovascular surgery marketing brochure (catalog number US-AS46-220001) distributed nationwide in the United States for the FloSeal Hemostatic Matrix NL, a surgical hemostatic agent used to control bleeding during medical procedures.
The brochure contains inaccurate information that does not align with the product's Instructions for Use (IFU) and Prescribing Information (PI). Discrepancies between promotional materials and official product labeling could potentially mislead healthcare providers about proper product use and clinical indications.
Healthcare facilities that received the brochure should discontinue distribution of the marketing material and ensure clinical staff reference the product's official Instructions for Use and Prescribing Information for accurate guidance. No product defects or adverse events have been reported.
The recalled product
- Product
- Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
- 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 (2)
- UDI/DI 85412656304
- 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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