The Recall Desk
Severity pendingFDA (Devices)·Z-0333-2026·Announced 2025-11-05

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Ch

Pending LLM rewrite. Source: FDA_DEVICE Z-0333-2026.

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 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
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 (1)

  • UDI:10887709057026/Lot: 14400616

Distribution

Distributed nationwide across the United States.