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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

Medtronic Perfusion Systems: TourniKwik Tourniquet Set Recalled Due to Incorrect Components

Agency Publication Date: July 23, 2024
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Summary

Medtronic Perfusion Systems is recalling 636 units of the TourniKwik Tourniquet Set (CFN 79012) across four specific manufactured lots. The recall was initiated because an incorrect component was accidentally placed within the tourniquet sets during manufacturing. Consumers should identify if they have the affected tourniquet sets by checking the model and serial numbers and contact their healthcare provider or the manufacturer for further instructions.

Risk

The inclusion of an incorrect component in a surgical tourniquet set could lead to device failure or improper function during medical procedures, potentially resulting in patient injury or delays in treatment.

What You Should Do

  1. Locate your TourniKwik Tourniquet Set and check for Model Number 79012.
  2. Verify the serial number and UDI on the packaging to see if it matches the affected lots: Serial Number 2023020354 (UDI: 20613994576358), Serial Number 2023020355 (UDI: 00673978186269), Serial Number 202304C012 (UDI: 20613994576358), or Serial Number 202305C244 (UDI: 20613994576358).
  3. If your product matches these identifiers, contact your healthcare provider or Medtronic Perfusion Systems for instructions on how to handle the device and discuss potential replacements.
  4. For additional questions or to report a problem, contact the FDA hotline 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

Contact manufacturer for guidance

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

Affected Products

Product: TourniKwik Tourniquet Set (CFN 79012)
Model / REF:
79012
UPC Codes:
20613994576358
00673978186269
Lot Numbers:
2023020354
2023020355
202304C012
202305C244

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94856
Status: Active
Manufacturer: Medtronic Perfusion Systems
Sold By: Medtronic Perfusion Systems
Manufactured In: United States
Units Affected: 636 units
Distributed To: Minnesota, Massachusetts, Utah, California, Florida

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.