FDA-Device2026-01-28Class IIPROCESSING DEFECT

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

OTHERNationwide distribution

Check ICU Medical Plum Duo IV Pump software

ICU Medical's Plum Duo Precision IV Pump may prevent clinicians from programming an automatic flush after piggyback therapy in certain situations. When this happens, the pump displays an error message and the flush cannot be set up, which could affect how medications are delivered.

  • If you use a Plum Duo Precision IV Pump (List 400020403 or 400021003), contact ICU Medical for guidance on your device's software version
  • Do not attempt to work around error messages; contact the manufacturer or your clinical engineering department for support
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 Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2026

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