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 infusion set
- Model numbers
- UDI/DI 00085412046327, Product Code 2C8571, Lot R25B24055
- 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 CONTIN-FLO system comprises non-vented IV infusion sets with a 0.2 micron filter designed for intravascular fluid delivery. It includes two luer activated valves and a backcheck valve in a 104-inch (2.6 m) line.
Why This Is Dangerous
The device's potential to leak could disrupt sterile fluid delivery and pose risks in clinical use, including under-delivery or contamination of IV administration.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics relying on these sets may need to replace stock quickly to maintain sterile IV therapy and avoid treatment delays.
Practical Guidance
How to identify if yours is affected
- Review packaging for Product Code 2C8571 and labeling for UDI 00085412046327.
- Check for Lot number R25B24055 on the device or pouch.
- Verify length 104 inches (2.6 meters) and non-vented design.
Where to find product info
Recall details and guidance are available on the FDA enforcement page linked to recall Z-0195-2026 and Baxter's official communications.
What timeline to expect
Hospitals and suppliers may complete replacements within 4-6 weeks after authorization.
If the manufacturer is unresponsive
- Document all attempts to contact Baxter; escalate to hospital risk management and file a report with the FDA MedWatch program if needed.
- Consider temporarily using alternative infusion sets as directed by clinical leadership.
How to prevent similar issues
- Implement a double-check system for device identifiers during procurement.
- Verify product codes and UDI before stocking IV sets.
- Maintain an up-to-date recall log and act on new alerts promptly.
Documentation advice
Retain recall notice, supplier communications, replacement confirmations, and any supporting purchasing records.
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Product Details
Model numbers/identifiers: UDI/DI 00085412046327; Lot numbers: R25B24055; Product Code 2C8571. Where sold: Nationwide distribution to healthcare providers in the United States. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 2C8571
- Lot numbers: R25B24055
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Safety Guide
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