Marketing brochure for Baxter Floseal hemostatic device contains inaccurate content
Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.
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 a Class II medical device recall involving inaccurate marketing materials rather than a product defect. No illnesses, injuries, or deaths have been reported. The hazard is documentation-related, representing a minor labeling error where the official Instructions for Use and Prescribing Information remain correct and available.
Plain-English summary
Baxter Healthcare Corporation is recalling a cardiovascular surgery marketing brochure (US-AS46-220001) for Baxter Floseal Hemostatic Matrix Fast Prep, product codes ADS201844 (5 mL) and ADS201845 (10 mL), distributed nationwide in the United States.
The marketing brochure contains information that does not align with the product's official Instructions for Use (IFU) and Prescribing Information (PI). This discrepancy between marketing materials and official documentation could create confusion among healthcare providers and surgical teams about proper product use and application.
The affected products have been distributed nationwide. Healthcare facilities and surgical departments that received or are using this marketing material should compare it against the official product documentation to verify compliance with correct usage protocols.
Healthcare providers should disregard the marketing brochure and rely exclusively on the official Instructions for Use and Prescribing Information when using Baxter Floseal Hemostatic Matrix Fast Prep. The official product documentation provides the authoritative guidance for safe and effective use of the device.
The recalled product
- Product
- Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
- 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) ADS201844
- UDI/DI 85412639598
- b) ADS201845
- UDI/DI 85412639604
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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