United StatesICU Medical Plum Duo, Plum Duo Precision IV Pump, and Plum Solo Precision IV Pump units with list numbers 400020401 (US; software 1.1.1–1.1.4), 400021001 (Philippines; software 1.1.0), 400020403 (US; software 1.2.2), 400021003 (Philippines; software 1.2.0), 400010401 (US; software 1.0.2), and 400011001 (Philippines; software 1.0.0) are recalled. The pumps’ piggyback flush feature may be prevented from being programmed if an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message appears, which can stop the intended flush from being delivered.
What's being recalled
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Recalling firm: ICU Medical, Inc., Lake Forest, IL, United States.
How to identify it
400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0 400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0 400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the country of Philippines.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada