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 administration set
- Model numbers
- UDI/DI 00085412071107, R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161 +10 more
- 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
IV solution sets deliver fluids and medications in clinical settings. The CLEARLINK CONTIN-FLO line is designed for non-vented use with specific valve configurations.
Why This Is Dangerous
Leakage from IV sets may lead to unintended fluid loss and potential safety concerns during administration.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must identify affected lots, stop use, and coordinate with Baxter for instructions and remediation.
Practical Guidance
How to identify if yours is affected
- Check product code 2C8541.
- Inspect for UDI/DI 00085412071107.
- Review lot numbers listed (e.g., R25A17123, R25B21024, etc.).
Where to find product info
Packaging and device labeling should show the UDI/DI and lot numbers; visit the FDA recall page for details.
What timeline to expect
Refunds or replacements are typically processed within several weeks once verified.
If the manufacturer is unresponsive
- Document all communications with Baxter.
- Escalate to hospital procurement if supplier is unresponsive.
- Consider contacting regulatory bodies if there is no resolution.
How to prevent similar issues
- Verify packaging labels before use.
- Maintain a recall contact list for medical devices.
- Ensure inventory is checked against recall notices before use.
Documentation advice
Keep product codes, UDI/DI, lot numbers, purchase receipts, and all correspondence with Baxter for records.
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Product Details
Product: CLEARLINK SYSTEM CONTIN-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541 Model numbers include UDI/DI 00085412071107 and listed lots Sold nationwide in the United States; states listed in recall notice Quantity recalled: 1,167,120 units Price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Non-vented IV solution sets with Luer Activated Valves included
- Udi/DI 00085412071107 and multiple Lot numbers listed
- Product Code 2C8541
- Case distributed across all listed US states
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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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