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 00085412048994, Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, R25C29185
- 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 CONTINU-FLO IV Solution Sets are used to deliver IV fluids in medical settings. They include non-vented tubing and Luer activated valves for controlled administration.
Why This Is Dangerous
Leakage can compromise fluid delivery and may require urgent clinical assessment to prevent under- or over-infusion.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects medical devices used in infusion therapy; patients in facilities could experience delays or changes in IV therapy if devices leak.
Practical Guidance
How to identify if yours is affected
- Check Product Code 2C8519
- Inspect label for UDI/DI 00085412048994
- Confirm length 112 inches (2.8 meters) and two CLEARLINK Luer Activated Valves
Where to find product info
Refer to the FDA recall page linked in Baxter communications and the product packaging for identifiers.
What timeline to expect
Remedy processing can take 4-8 weeks for replacement or instructions.
If the manufacturer is unresponsive
- Escalate to hospital patient safety officer
- File a consumer protection complaint if Baxter is unresponsive
- Consult healthcare provider for interim infusion safety measures
How to prevent similar issues
- Verify device codes before procurement
- Ask distributors for recall status of IV sets
- Maintain inventory records for recalls and replacements
Documentation advice
Keep a copy of the recall notice, take photos of product labels and codes, and save all correspondence with Baxter and healthcare facilities
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Product Details
CLEARLINK SYSTEM CONTINU-FLO IV Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters). Product Code 2C8519. UDI/DI 00085412048994. Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185. Sold: 473,040 units. Distribution: US nationwide including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Recall Date: 2025-08-29. Status: Active. Brand: Baxter Healthcare. Cat
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2C8519
- 112-inch (2.8 meters) length
- Non-Vented, two CLEARLINK Luer Activated Valves with Backcheck Valve
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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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