FDA-Device2026-01-28Class IIPROCESSING DEFECT

ICU Medical Plum Duo Infusion Pump recalled for piggyback flush programming error

OTHERNationwide distribution

Check your ICU Medical Plum Duo pump software

ICU Medical Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic flush after piggyback therapy. When attempting to set up this flush feature, the pump may display an error message that blocks the programming, even though the flush itself is a safe feature.

  • If you use a Plum Duo pump (List Number 400020401 in US or 400021001 in Philippines), contact ICU Medical for software version information and updates
  • Check your pump's software version against the affected versions (1.1.0, 1.1.1, 1.1.2, 1.1.3, 1.1.4)
  • Do not attempt to work around the error message; contact your device support team for guidance
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.

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 Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2026

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