The Recall Desk
Severity pendingFDA (Devices)·Z-0202-2026·Announced 2025-10-22

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backch

Pending LLM rewrite. Source: FDA_DEVICE Z-0202-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

IV sets may leak.

The recalled product

Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
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 (2)

  • UDI/DI 00085412565743
  • Lot numbers: R25C28048

Distribution

Distributed nationwide across the United States.