Baxter Flo-Thru Intraluminal Shunt recalled for marketing brochure inaccuracy
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
What this means for you
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: The recall addresses a labeling discrepancy where marketing materials contain inaccurate information relative to official product documentation. With no reported illnesses or injuries and the hazard being informational rather than a device defect, this falls under minor labeling errors.
Plain-English summary
Baxter Healthcare Corporation is recalling a cardiovascular surgery marketing brochure (US-AS46-220001) that was distributed for the Baxter Flo-Thru Intraluminal Shunt. The brochure contains inaccurate content that does not align with some product sizes' official Instructions for Use (IFU) or Prescribing Information (PI).
The affected product includes Baxter Flo-Thru Intraluminal Shunt models FT12100 (1.00 GLOBAL) through FT12300 (3.00 GLOBAL), distributed nationwide in the United States. Healthcare facilities and clinicians currently using these devices should consult the official product Instructions for Use and Prescribing Information rather than relying on the recalled marketing brochure.
The recalled product
- Product
- Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.
- 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 (19)
- All serial numbers
- a) Product Code FT12100
- UDI/DI 85412532431
- b) Product Code FT12125
- UDI/DI 85412532448
- c) Product Code FT12150
- UDI/DI 85412532455
- d) Product Code FT12175
- UDI/DI 85412532462
- e) Product Code FT12200
- UDI/DI 85412532479
- f) Product Code FT12225
- UDI/DI 85412532486
- g) Product Code FT12250
- UDI/DI 85412532493
- h) Product Code FT12275
- UDI/DI 85412532509
- i) Product Code FT12300
- UDI/DI 85412532516
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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