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
- 00085412048956, R25C03055, R25C04062, R25C29086
- 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 Solution Set DUO-VENT is an IV administration set used to deliver fluids and medications via IV therapy. It includes a Luer Activated Valve and long tubing. This recall concerns leakage risk.
Why This Is Dangerous
A leak in the IV set could result in unintended loss of IV fluids, inaccurate dosing, or potential contamination of the administration line.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and clinics may need to halt use of affected lots, procure replacements, and document returns, potentially impacting patient care temporarily.
Practical Guidance
How to identify if yours is affected
- 1. Check product code 2C8419 on the device and packaging.
- 3. Confirm lot codes R25C03055, R25C04062, or R25C29086.
Where to find product info
Identification codes are printed on the packaging and on the device label.
What timeline to expect
Refunds or replacements typically take 4-6 weeks after submission.
If the manufacturer is unresponsive
- Escalate to Baxter Healthcare via the FDA recall page.
- File a complaint with the CPSC if needed.
How to prevent similar issues
- Verify recall status before procurement of IV sets.
- Request recall documentation from suppliers.
- Use only approved, non-recalled IV sets for patient care.
Documentation advice
Keep copies of the recall notice, purchase receipts, correspondence with Baxter, and photos of the product codes.
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Product Details
Brand: Baxter Healthcare Product: CLEARLINK System Solution Set DUO-VENT with CLEARLINK Luer Activated Valve Specifications: 10 drops/mL, 92-inch (2.3 m) tubing Product code: 2C8419 UDI/DI: 00085412048956 Lot codes: R25C03055, R25C04062, R25C29086 Quantity: 136,512 units Sold/distributed: Nationwide in the United States Sold since: Unknown Price: Unknown Manufacturer: Baxter Healthcare
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product code 2C8419
- Lot codes: R25C03055, R25C04062, R25C29086
- Nationwide distribution in the U.S.
- High-hazard recall with potential leakage risk
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Safety Guide
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