FDA DevicesClass II
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Ph...
Published: January 28, 2026Recall ID: Z-1118-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Affected Products
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Forest |
| State | IL |
| Event id | 98128 |
| Address 1 | 600 N Field Dr |
| Code info | 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0 |
| Postal code | 60045-4835 |
| Report date | 20260128 |
| Product type | Devices |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260116 |
Overview
- Recalling FirmICU Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the country of Philippines.