Baxter Coseal Premix Surgical Sealant: Marketing Brochure Information Inaccuracy
Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's 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 is an FDA Class II medical device recall based on a marketing brochure containing information that conflicts with the product's official Instructions for Use and Prescribing Information. No illnesses or injuries have been reported, and the actual product instructions remain accurate.
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter Coseal Premix, a surgical sealant, due to inaccurate information in a marketing brochure that conflicts with the product's official documentation.
The Cardiovascular Surgery marketing brochure (designated US-AS46-220001) was distributed nationwide in the US. This brochure contains content that does not align with the product's Instructions for Use (IFU) or Prescribing Information (PI).
The recalled products are identified by product codes 934070, 934071, and 934072. Product code 934070 has UDI/DI 5413765404610, and product code 934071 has UDI/DI 5413765404627. Product code 934072 does not have an associated UDI/DI.
The recalled product
- Product
- Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
- 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 (6)
- All serial numbers a) Product code 934070
- UDI/DI 5413765404610
- b) Product code 934071
- UDI/DI 5413765404627
- c) Product code 934072
- have no UDI/DI.
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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