FDAClass IIJanuary 28, 2026

ICU Medical Plum Solo Precision IV Pump recall

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

Why was ICU Medical Plum Solo Precision IV Pump recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0

Product
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Recalling firm
ICU Medical, Inc.
Distribution
Worldwide distribution - US Nationwide and the country of Philippines.
Recall date
January 28, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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