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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Baxter Healthcare Corporation: Surgical Tools and Cardiovascular Brochures Recalled for Inaccurate Content

Agency Publication Date: April 12, 2024
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Summary

Baxter Healthcare Corporation is recalling approximately 278,751 marketing brochures for several surgical and cardiovascular devices, including the Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probes. The brochures contain inaccurate information that contradicts the official Instructions for Use (IFU) for these medical devices. These materials were distributed worldwide, including nationwide in the United States and in Canada, Ireland, the United Kingdom, and Hong Kong.

Risk

Inaccurate marketing information may lead healthcare providers to use these surgical tools in ways that are not supported by the product's official instructions, potentially leading to surgical complications or improper device performance during cardiovascular procedures.

What You Should Do

  1. Identify if you have the affected marketing materials by checking for brochure reference numbers US-AS18-210002 (Surgical Tools Brochure 2021), US-AS18-210004 (Surgical Tools Website v1), or US-AS46-230002 (CV Specialty Brochure US version).
  2. Verify if your medical facility uses the related devices: Flo-Rester (item numbers 50100 through 60450BIOS), Flo-Thru Intraluminal Shunt (item numbers FT12100 through FT12300), or Vascular Probes (item numbers 7081015 through 7452025ES).
  3. Immediately stop using and discard any of the physical or digital marketing brochures listed above.
  4. Always refer strictly to the official 'Instructions for Use' (IFU) provided with the physical device for proper handling and surgical procedures.
  5. Contact Baxter Healthcare Corporation at their Deerfield, Illinois headquarters or through your local representative for further instructions regarding updated marketing materials.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of marketing brochures

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Flo-Rester Disposable Internal Vessel Occluder
Model / REF:
50100
50125
50150
50175
50200
50225
50250
50275
50300
50350
50400
50450BIOS
60100
60125BIOS
60150BIOS
60175
60200BIOS
60225BIOS
60250BIOS
60275
60300
60350
60400BIOS
60450BIOS
Lot Numbers:
UDI/DI 00085412532592
UDI/DI 00085412532684
UDI/DI 00085412532608
UDI/DI 00085412532691
UDI/DI 00085412532431
UDI/DI 00085412532448
UDI/DI 00085412532455
UDI/DI 00085412532462
UDI/DI 00085412532479
UDI/DI 00085412532486
UDI/DI 00085412532493
UDI/DI 00085412532509
UDI/DI 00085412532516
UDI/DI 00085412532110
UDI/DI 00085412532127
UDI/DI 00085412532134
UDI/DI 00085412532141
UDI/DI 00085412532158
UDI/DI 00085412532523
UDI/DI 00085412532615
UDI/DI 00085412532530
UDI/DI 00085412532622
UDI/DI 00085412532547
UDI/DI 00085412532639
Product: Flo-Thru Intraluminal Shunt
Model / REF:
FT12100
FT12125
FT12150
FT12175
FT12200
FT12225
FT12250
FT12275
FT12300
Lot Numbers:
UDI/DI 00085412532004
UDI/DI 00085412532011
UDI/DI 00085412532042
UDI/DI 00085412532059
UDI/DI 00085412532066
UDI/DI 00085412532073
UDI/DI 00085412532080
UDI/DI 00085412532097
UDI/DI 00085412532103
Product: Vascular Probe Intravascular Probe
Model / REF:
7081015
7081015ES
7081520
7081520ES
7082025
7082025ES
7151015
7151015ES
7151520
7151520ES
7152025
7152025ES
7451015
7451015ES
7451520
7451520ES
7452025
7452025ES
Lot Numbers:
UDI/DI 00085412532554
UDI/DI 00085412532646
UDI/DI 00085412532561
UDI/DI 00085412532653
UDI/DI 00085412532578
UDI/DI 00085412532660
UDI/DI 00085412532585
UDI/DI 00085412532677
UDI/DI 00085412531908
UDI/DI 00085412531915
UDI/DI 00085412531922
UDI/DI 00085412531939
UDI/DI 00085412531946
UDI/DI 00085412531953
UDI/DI 00085412531960
UDI/DI 00085412531977
UDI/DI 00085412531984
UDI/DI 00085412531991

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94119
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 3 products (83971 units; 112760 units; 82020 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.