Marketing brochures for Baxter surgical vessel occluders contain inaccurate information
Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving marketing brochures with information that does not align with official product instructions. No illnesses or injuries have been reported, but the inaccuracy poses a risk of potential harm if healthcare providers rely on the incorrect information during use of these surgical devices.
Plain-English summary
Baxter Healthcare Corporation is recalling marketing brochures for three cardiovascular and surgical devices: Flo-Rester Disposable Internal Vessel Occluders, Flo-Thru Intraluminal Shunts, and Vascular Probe Intravascular Probes. The brochures contain inaccurate content that does not align with the official Instructions for Use (IFU) for these products.
The affected marketing materials were distributed worldwide to customers in the United States, Canada, Ireland, United Kingdom, and Hong Kong. Approximately 83,971 units are involved in this recall.
The recall addresses potential confusion resulting from inaccurate marketing information that differs from the official product instructions.
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: Flo-Rester Disposable Internal Vessel…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 83,971
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
- UDI/DI 00085412532592
- b) 50125
- UDI/DI 00085412532684
- c) 50150
- UDI/DI 00085412532608
- d) 50175
- UDI/DI 00085412532691
- e) 50200
- UDI/DI 00085412532431
- f) 50225
- UDI/DI 00085412532448
- g) 50250
- UDI/DI 00085412532455
- h) 50275
- UDI/DI 00085412532462
- i) 50300
- UDI/DI 00085412532479
- j) 50350
- UDI/DI 00085412532486
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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