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, PREGNANT, INFANTS
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 00085412071664, Lot numbers R25D01161
- Sizes
- 102-inch (2.6 meters)
- 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
The CLEARLINK SYSTEM CONTINU-FLO IV set is a non-vented intravenous administration set used to deliver IV fluids in clinical settings. It includes a 0.2 micron filter and multiple valves for controlled flow.
Why This Is Dangerous
Leakage can alter flow rate and volume, potentially resulting in under- or over-delivery of IV medications and fluids, posing patient safety risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must replace affected sets to maintain safe IV therapy and avoid treatment delays or dosing errors.
Practical Guidance
How to identify if yours is affected
- Check for Product Code 2C8593 on the device packaging or documentation.
- Inspect for UDI/DI 00085412071664 and Lot number R25D01161.
- Confirm the length is 102 inches and that the unit has a 0.2 micron filter and three CLEARLINK valves.
Where to find product info
Visit Baxter’s recall notices and the FDA enforcement page linked in the recall document.
What timeline to expect
4-8 weeks for refunds or replacements after verification and return processing.
If the manufacturer is unresponsive
- Escalate to hospital safety officers or procurement managers.
- Document all communications with Baxter and retain unit lot codes for records.
How to prevent similar issues
- Verify product codes and lot numbers before accepting IV sets.
- Purchase from authorized distributors and confirm device integrity before use.
- Establish a recall monitoring process for IV sets and other critical supplies.
Documentation advice
Keep the recall notice, take clear photos of lot codes and product codes, retain purchase receipts, and log all communications with Baxter.
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Product Details
Model numbers: UDI/DI 00085412071664; Lot numbers R25D01161. Where sold: Nationwide US distribution 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, WV. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2C8593
- Lot numbers R25D01161
- 102-inch (2.6 m) length
- 0.2 micron filter with 3 CLEARLINK valves and 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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