Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brand
- Baxter Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Baxter Healthcare
- Product type
- IV Extension Set (ClearLink System)
- Model numbers
- UDI/DI 00085412049007, Lot numbers: R25C31031
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
IV sets may leak.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
About This Product
CLEARLINK System Extension Set is used in IV therapy to extend IV lines. It connects to IV catheters to deliver fluids. The set includes a Luer activated valve and retractable collar for connection and control.
Why This Is Dangerous
Leakage can lead to unintended IV fluid leakage, potential contamination, and infection risk. Leakage can also compromise medication delivery to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to patients if leakage occurs during IV therapy. Hospitals and clinics may face supply disruption and increased safety checks.
Practical Guidance
How to identify if yours is affected
- Check UDI/DI 00085412049007 on the device label.
- Check Lot number R25C31031 on packaging or device label.
- Verify Product Code 2C8632 and 14-inch length.
Where to find product info
UDI/DI and Lot numbers are on the product label and packaging. The FDA recall page provides official instructions.
What timeline to expect
4-8 weeks for refunds or replacements, depending on Baxter’s process.
If the manufacturer is unresponsive
- Document all attempts to contact Baxter and recall notifications.
- escalate to FDA/ CPSC recall channels if needed.
- Consider seeking legal advice for unresolved safety concerns.
How to prevent similar issues
- Verify recall status before purchasing IV extension sets.
- Purchase from authorized distributors.
- Keep an updated list of recalled lots and models.
Documentation advice
Save recall notices, take photos of labels, log communication with Baxter, and retain receipts or invoices.
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Product Details
Model/Code: 2C8632; UDI/DI: 00085412049007; Lot: R25C31031. Quantity: 2304 units. Sold nationwide in the United States.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Leak hazard in CLEARLINK System Extension Set
- Model/UDI: 00085412049007; Lot: R25C31031
- Recall status: ACTIVE as of 2025-10-22
- Sold nationwide in the US
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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