The Recall Desk
HighFDA (Devices)·Z-0190-2026·Announced 2025-10-22

[pending] CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 m

Pending LLM rewrite. Source: FDA_DEVICE Z-0190-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

IV sets may leak.

The recalled product

Product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Manufacturer
Baxter Healthcare Corporation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI/DI: 00085412048956
  • Lot Codes: R25C03055
  • R25C04062
  • and R25C29086

Distribution

Distributed nationwide across the United States.