Quick Facts at a Glance
- Recall Date
- August 8, 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
- Intravascular administration set
- Model numbers
- UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 8, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
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. Notification method: Letter
About This Product
Continu-Flo intravascular solution sets are used to administer IV fluids and medications through a sterile tubing system in clinical settings. They connect to IV catheters and infusion pumps to deliver controlled doses.
Why This Is Dangerous
Tubing separation can disrupt infusion, risking incorrect dosing or agents entering unintended pathways. In some cases it could lead to air embolism or patient harm if not detected promptly.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of affected lots, review inventory, and coordinate replacements or refunds with Baxter.
Practical Guidance
How to identify if yours is affected
- Check for Lot R24I20079 on the packaging and UDI/DI 00085412048994.
- Verify product length, non-vented design, and valve configuration (2 Clearlink Luer Activated Valves; Backcheck Valve).
- Confirm 112" (2.8 m) tubing and 10 drops/mL flow rate.
Where to find product info
Recall notice and FDA enforcement page. Contact Baxter Healthcare for instructions and potential replacement/refund details.
What timeline to expect
Typical recall processing may take several weeks. Baxter will provide specific timelines in the recall notice.
If the manufacturer is unresponsive
- Document all contact attempts with Baxter and your supplier.
- Escalate to hospital risk management or regulatory authorities if no response within the stated timeframe.
How to prevent similar issues
- Verify recall status for IV sets before use.
- Establish inventory controls to separate recalled lots.
- Train staff to stop using recalled devices immediately and follow recall instructions.
- Check for UDI and Lot numbers on all IV sets before use.
Documentation advice
Keep the recall letter, note the affected lot numbers, take photos of packaging and labels, preserve used devices for potential investigation.
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Product Details
Product: Continu-Flo Solution Set, Non-Vented, 112" (2.8 m). 10 drops/mL. 2 Clearlink Luer Activated Valves. Backcheck Valve. Product Code REF 2C8519. Intravascular administration set. Brand: Baxter Healthcare. UDI/DI: 00085412048994. Lot Number: R24I20079. Exp. 9/21/2026.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: US Nationwide
- Hazard Level: HIGH
- Classification: Class II
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Safety Guide
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