The Recall Desk
Severity pendingFDA (Devices)·Z-0357-2026·Announced 2025-11-05

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

Pending LLM rewrite. Source: FDA_DEVICE Z-0357-2026.

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

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

The recalled product

Product
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Manufacturer
ICU Medical, Inc.

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)

  • Lot:14407070
  • 14384996
  • 14391949
  • Distributed in Canada

Distribution

Distributed nationwide across the United States.