Baxter Healthcare Recalls 136,512 CLEARLINK IV Sets DUO-VENT for Leak Risk (2025)
Baxter Healthcare recalled 136,512 CLEARLINK System Solution Set DUO-VENT IV sets distributed nationwide in the United States after detecting a leak risk. The Luer Activated Valve design may leak, potentially compromising IV administration. Hospitals and patients should stop using the device immediately and follow Baxter recall 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.
- 2. Verify UDI 00085412048956.
- 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.
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.