ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Pending LLM rewrite. Source: FDA_DEVICE Z-1118-2026.
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
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
The recalled product
- Product
- ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
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 (6)
- 400020401 (US)
- Software Versions: 1.1.1
- 1.1.2
- 1.1.3
- 1.1.4 400021001 (Philippines)
- Software Versions: 1.1.0
Distribution
Distributed nationwide across the United States.
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