Baxter Vascular Probe Marketed with Inaccurate Prescribing Information
Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.
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 IFU/PI, with no reported illnesses or injuries. The hazard is informational rather than a physical product defect, fitting the rubric for minor labeling errors.
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter Vascular Probe models distributed nationwide in the United States. The recall concerns a cardiovascular surgery marketing brochure (US-AS46-220001) that contains inaccurate content.
The marketing brochure 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 about proper product use and handling.
Healthcare facilities and providers who received the marketing brochure should disregard it and rely exclusively on the official Instructions for Use and Prescribing Information. No illnesses or injuries have been reported related to this discrepancy. Baxter Healthcare can be contacted for replacement materials or clarification.
The recalled product
- Product
- Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, 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 (19)
- a) 7081015: UDI/DI 0338-9564-17
- b) 7081520: UDI/DI 0338-9564-18
- c) 7082025: UDI/DI 0338-9564-19
- d) 7151015: UDI/DI 0338-9564-12
- e) 7151520: UDI/DI 0338-9564-11
- f) 7152025: UDI/DI 0338-9564-13
- g) 7451015: UDI/DI 0338-9564-14
- h) 7451520: UDI/DI 0338-9564-15
- i) 7452025: UDI/DI 0338-9564-16
- j) 7081015ES: UDI/DI 0338-9564-10
- k) 7081520ES: UDI/DI 0338-9564-26
- l) 7082025ES: UDI/DI 0338-9564-27
- m) 7151015ES: UDI/DI 0338-9564-21
- n) 7151520ES: UDI/DI 0338-9564-20
- o) 7152025ES: UDI/DI 0338-9564-22
- p) 7451015ES: UDI/DI 0338-9564-24
- q) 7451520ES: UDI/DI 0338-9564-23
- r) 7452025ES: UDI/DI 0338-9564-25
- 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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