Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1119-2026 — ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

U.S. FDA — Device Enforcement · United States · 2025-12-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1119-2026
Date of alert
2025-12-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
400020403
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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