ICU Medical, Inc.: ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ICU Medical, Inc.
- Product
- ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Philippines.
- Recall initiated
- 2025-12-15
- Code info
- 400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Forest
- State
- IL
- Country
- United States
- Event id
- 98128
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