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, 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 00085412046310, R25C26161, R25D01031
- 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
CONTINU-FLO Solution Set is a non-vented IV administration set with CLEARLINK valves used for delivering intravenous therapies.
Why This Is Dangerous
Leakage at connections or valves can cause unintended fluid leakage during IV administration, potentially compromising therapy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using these sets may need to halt use, inspect inventory, and coordinate with Baxter for remediation; no injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Identify the device as CONTINU-FLO Solution Set with two CLEARLINK Luer Activated Valves and a Backcheck Valve.
- Check for UDI/DI 00085412046310 on the label.
- Check for lot numbers R25C26161 or R25D01031 on the packaging or device.
- If any match, treat as affected and follow recall instructions.
Where to find product info
Recall information is available on the FDA enforcement page linked in the article and Baxter's recall communications.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after initiation.
If the manufacturer is unresponsive
- Document all contact attempts with Baxter Healthcare Corporation.
- Consider contacting the FDA or local health authorities if responses are slow.
How to prevent similar issues
- Purchase IV sets only from authorized medical distributors.
- Verify device identifiers before use in clinical settings.
- Maintain a current inventory log to quickly identify recalled lots.
Documentation advice
Keep copies of the recall notice, labels, model numbers, serials, Lot numbers, photos, and all correspondence with Baxter or healthcare providers.
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Product Details
Brand: Baxter Healthcare. Product: CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve. Product code: 2C6255. Model numbers/Lot numbers: UDI/DI 00085412046310; Lot numbers R25C26161 and R25D01031. Sold in: United States nationwide. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 49,200 units recalled nationwide in the US
- Product code 2C6255
- Hazard: IV sets may leak
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Safety Guide
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