Medical Device Recall: Baxter Ostene Hemostasis Material Marketing Brochure Inaccuracy
Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do 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: This is an FDA Class II recall for a documentation discrepancy between marketing materials and official Instructions for Use. No injuries or illnesses have been reported. The hazard is theoretical—potential for improper use if providers rely on inaccurate marketing content.
Plain-English summary
Baxter Healthcare Corporation is recalling marketing brochure US-AS46-220001 for the Ostene Hemostasis Material (Product Codes: 1503831 [3.5 G], 1503832 [2.5 G], and 1503833 [1.0 G]). The brochure contains inaccurate information that does not align with the product's Instructions for Use (IFU) and Prescribing Information (PI).
The discrepancy between the marketing material and the official product documentation could potentially result in improper use of the device if healthcare providers rely on the inaccurate brochure content instead of the correct IFU/PI.
This recall affects Baxter Ostene Hemostasis Material distributed nationwide across the United States. No injuries or illnesses have been reported.
Healthcare facilities and providers should disregard the recalled marketing brochure and refer only to the product's official Instructions for Use and Prescribing Information for correct usage guidance.
The recalled product
- Product
- Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
- 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)
- All serial numbers
- 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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