FDA-Device2026-01-28Class IIPROCESSING DEFECT

ICU Medical Plum Solo Precision IV Pump recalled for piggyback flush programming error

OTHERNationwide distributionMedical devicesBaby & kids

What this means

ICU Medical's Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic line flush after piggyback therapy. In certain situations, the pump displays an error message that blocks the flush from being set up, even though the flush is a normal part of the treatment process.

  • If you use or manage these pumps, contact ICU Medical for guidance on the affected software versions (1.0.2 for US model 400010401 or 1.0.0 for Philippines model 400011001)
  • Do not attempt workarounds; follow your facility's protocol and ICU Medical's instructions
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Philippines.
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2026

More ICU Medical recalls

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