The Recall Desk
HighFDA (Devices)·Z-0192-2026·Announced 2025-10-22

[pending] CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backchec

Pending LLM rewrite. Source: FDA_DEVICE Z-0192-2026.

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 CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
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 (7)

  • UDI/DI 00085412048994
  • Lot numbers: R25A25147
  • R25B21086
  • R25C20130
  • R25C25055
  • R25C25161
  • and R25C29185

Distribution

Distributed nationwide across the United States.