The Recall Desk
HighFDA (Devices)·Z-0331-2026·Announced 2025-11-05

[pending] ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

Pending LLM rewrite. Source: FDA_DEVICE Z-0331-2026.

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

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

The recalled product

Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
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:10887709094670/Lot: 14391937

Distribution

Distributed nationwide across the United States.