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
- UID/DI 00085412625553, Lot R25C08147
- Sizes
- 96 inches
- 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 sets deliver fluids and medications through a patient’s vein. They are used in clinical settings by healthcare professionals.
Why This Is Dangerous
Leakage from an IV set could compromise the sterile delivery of IV fluids and medications, necessitating device replacement.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to replace affected sets, causing logistical and workflow disruptions and potential treatment delays.
Practical Guidance
How to identify if yours is affected
- Verify product label shows CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET
- Confirm length 96 inches (2.4 m)
- Check Product Code 2H8519
- Inspect UID/DI 00085412625553 on the label
- Check Lot number R25C08147 on packaging
Where to find product info
Look on device labeling and packaging for UID/DI and Lot number details.
What timeline to expect
Refunds or replacements are typically processed within 4-6 weeks after verification.
If the manufacturer is unresponsive
- Document all outreach attempts to Baxter
- Escalate to a healthcare administrator or regulatory body if needed
- Consider filing a report with the relevant authority if no response
How to prevent similar issues
- Verify DEHP-free status before purchasing IV sets
- Request non-DEHP alternatives from suppliers
- Check for recalls before using new lots or product codes
Documentation advice
Keep the recall notice, packaging, labels, receipts, and all correspondence with Baxter for records.
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Product Details
Model numbers: UID/DI 00085412625553; Lot numbers: R25C08147; Product Code: 2H8519; Length: 96 inches (2.4 m); Units recalled: 18,720; Distribution: U.S. nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2H8519
- UID/DI 00085412625553 on label
- Lot R25C08147 on packaging
- Length 96 inches (2.4 m)
- US nationwide distribution
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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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