Baxter FloSeal Hemostatic Matrix Recalled for Marketing Brochure Inaccuracies
Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with 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: FDA Class II recall of marketing materials containing inaccurate information. No illnesses or injuries reported. The hazard is documentation discrepancy between marketing brochure and official product guidance, constituting a minor labeling error.
Plain-English summary
Baxter Healthcare Corporation has issued a Class II recall for Baxter FloSeal Hemostatic Matrix RECOTHROM (product codes ADS202105 and ADS202110), distributed nationwide in the United States. The recall was initiated because a cardiovascular surgery marketing brochure (US-AS46-220001) distributed for these products contains inaccurate content that does not align with the product's Instructions for Use (IFU) and Prescribing Information (PI).
Healthcare providers and facilities using these products should refer to the official Instructions for Use and Prescribing Information for accurate product information and guidance.
The recalled product
- Product
- Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
- 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 (4)
- All serial numbers a) ADS202105
- UDI/DI 85412827957
- b) ADS202110
- UDI/DI 85412827896
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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