The Recall Desk
Severity pendingFDA (Devices)·Z-0199-2026·Announced 2025-10-22

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activate

Pending LLM rewrite. Source: FDA_DEVICE Z-0199-2026.

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 EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
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 00085412049021
  • Lot numbers: R25A21024

Distribution

Distributed nationwide across the United States.