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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

Baxter Medical Solution Sets Recalled for Inverted Clamps and Unusable Tubing

Agency Publication Date: January 22, 2025
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Summary

Baxter Healthcare Corporation is recalling specific lots of its Solution Sets with Duo-Vent Spikes, including the Clearlink and Continu-Flo systems. The recall was issued because the side clamps on the tubing may be inverted, which can make the medical tubing completely unusable for treatments. No incidents or injuries have been reported to date, but the company is taking this action to ensure healthcare providers have functional equipment.

Risk

The inverted side clamps prevent the medical tubing from functioning properly, which could lead to delays in administering fluids or medications to patients. This defect makes the medical set unusable in a clinical setting.

What You Should Do

  1. This recall affects Baxter Solution Sets with Duo-Vent Spikes (REF 2R8404), Clearlink System Solution Sets (REF 2R8538), and Continu-Flo Solution Sets (REF UC8519).
  2. Identify affected products by checking the lot numbers on your packaging: DR24C22079 (exp. 3/247/2026), DR24H23086 (exp. 8/26/2026), DR24C15109 (exp. 3/16/2026), or DR24B21017 (exp. 02/28/2026).
  3. Stop using the recalled device.
  4. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter Solution Set with Duo-Vent Spike
Model / REF:
2R8404
Lot Numbers:
DR24C22079 (exp. 3/247/2026)
DR24H23086 (exp. 8/26/2026)
UDI:
00085412676630

Recall #: Z-1009-2025

Product: Baxter Clearlink System Solution Set with Duo-Vent Spike
Model / REF:
2R8538
Lot Numbers:
DR24C15109 (exp. 3/16/2026)
UDI:
00085412676647

Recall #: Z-1010-2025

Product: Baxter Continu-Flo Solution Set with Duo-Vent Spike
Model / REF:
UC8519
Lot Numbers:
DR24B21017 (exp. 02/28/2026)
UDI:
00085412486512

Recall #: Z-1011-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95929
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Direct distribution to healthcare facilities and providers
Manufactured In: United States
Distributed To: Minnesota, Missouri, Virginia, Texas, California, Massachusetts, Florida, South Carolina

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.