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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/Home Healthcare

Baxter Healthcare Corporation: Clearlink Solution Sets Recalled for Potential Drip Chamber Leaks

Agency Publication Date: March 14, 2024
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Summary

Baxter Healthcare Corporation is recalling approximately 26,592 units of the CLEARLINK Non-DEHP Solution Set Luer Lock Adapter (Product Code 2R8401). This medical device is being recalled because of potential leaks originating from the drip chamber, which can disrupt the delivery of medications or fluids to patients. Consumers should identify if they have the affected product code and lot number and contact their healthcare provider or the manufacturer immediately for further instructions.

Risk

A leak in the drip chamber can lead to a loss of sterile integrity or an interruption in treatment, potentially causing infection or under-dosing of critical medication. There are currently no specific reports of injuries listed, but the defect poses a moderate safety risk during clinical use.

What You Should Do

  1. Identify if you have the affected CLEARLINK Non-DEHP Solution Set Luer Lock Adapter by checking the packaging for Product Code 2R8401 and Lot Number R23A02062.
  2. Check the expiration date on the package to see if it matches the recalled date of 1 Jan 2025.
  3. If you have the affected product, contact your healthcare provider or Baxter Healthcare Corporation at 1 Baxter Pkwy, Deerfield, Illinois, to report the affected units and receive further instructions.
  4. Contact Baxter Healthcare Corporation to inquire about potential product returns or refunds related to this recall.
  5. For additional questions or to report a problem, 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

Manufacturer Notification and Guidance

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

Affected Products

Product: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter
Model / REF:
Product Code 2R8401
UDI/DI 00085412565767
Lot Numbers:
R23A02062 (exp. 1 Jan 2025)
Date Ranges: 1 Jan 2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93930
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospital and clinical supply chains
Manufactured In: United States
Units Affected: 26,592 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.