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 Set
- Model numbers
- UDI/DI 00085412565743, R25C28048 (Lot)
- 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 used to administer intravenous fluids in clinical settings. It features three Luer Activated Valves and a Backcheck Valve in a non-vented design.
Why This Is Dangerous
Leakage in IV sets can compromise sterile delivery and fluid administration during patient care. The leak could require device replacement and interrupt treatment.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to halt use of affected lots and replace devices, potentially impacting patient care workflows and supplier logistics.
Practical Guidance
How to identify if yours is affected
- Check Product Code 2R8537 on the device label
- Read UDI/DI 00085412565743 on the packaging
- Look for Lot number R25C28048
- Check that the device is Non-DEHP and Non-Vented with three CLEARLINK Luer Activated Valves
Where to find product info
Recall notice on FDA enforcement page and Baxter's recall communications.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with Baxter and your supplier.
- Escalate to hospital procurement and report to the FDA if needed.
How to prevent similar issues
- Verify DEHP-free equipment when selecting IV sets.
- Check for Luer Activated Valves and Backcheck Valve features before use.
- Maintain an updated recall monitoring process for clinical devices.
Documentation advice
Retain recall notices, purchase records, device labeling, UDI, and all correspondence related to the recall.
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Product Details
Product Code: 2R8537. UDI/DI: 00085412565743. Lot numbers: R25C28048. Distribution: Nationwide in the United States. Sold through: Healthcare facilities and providers. Quantity: 12,720 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2R8537
- Lot R25C28048
- Three CLEARLINK Luer Activated Valves
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Safety Guide
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