Baxter surgical tool marketing brochures contain inaccurate Instructions for Use
Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.
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: Class II device recall involving inaccurate marketing materials and documentation discrepancies with no reported illnesses, injuries, or deaths. Per the severity rubric, minor labeling errors and documentation issues without reported harm score 2 (Moderate).
Plain-English summary
Baxter Healthcare Corporation is recalling marketing brochures for several surgical tools, including the Vascular Probe, Flo-Thru Intraluminal Shunt, and Flo-Rester Disposable Internal Vessel Occluder. Approximately 82,020 units of these devices are affected.
The recalled marketing brochures were distributed under Reference numbers US-AS18-210002, US-AS18-210004, and US-AS46-230002. These materials contain inaccurate content that does not align with the products' Instructions for Use (IFU).
The affected products were distributed worldwide to customers in the United States, Canada, Ireland, United Kingdom, and Hong Kong. Customers who have received these marketing brochures should refer to the actual product Instructions for Use for accurate device information.
The recalled product
- Product
- Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a)…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Surgical Tools
- Affected units
- 82,020
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 (20)
- US-AS18-210004 Surgical Tools Website v1
- and US-AS46-230002 CV Specialty Brochure US version
- Flo-Thru Intraluminal Shunt: ALL SERIAL NUMBERS: a) 7081015
- UDI/DI00085412532554
- b) 7081015ES
- UDI/DI00085412532646
- c) 7081520
- UDI/DI00085412532561
- d) 7081520ES
- UDI/DI00085412532653
- e) 7082025
- UDI/DI00085412532578
- f) 7082025ES
- UDI/DI00085412532660
- g) 7151015
- UDI/DI00085412532585
- h) 7151015ES
- UDI/DI00085412532677
- i) 7151520
- UDI/DI00085412531908
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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