FDA Class II Recall: Plum Solo Precision IV Pump, 40001-0401 by ICU Medical, Inc.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Plum Solo Precision IV Pump, 40001-0401 -- and the recall number Z-2311-2026. If it matches, stop using or distributing it and contact ICU Medical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ICU Medical, Inc. and the affected product is described in FDA's record as: Plum Solo Precision IV Pump, 40001-0401. FDA's stated reason for the recall is: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.. The recall is tracked under FDA recall number Z-2311-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

ICU Medical, Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

ICU Medical, Inc. recalled Plum Solo Precision IV Pump, 40001-0401. FDA's record states the reason for recall as: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.. The recall is logged under FDA recall number Z-2311-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Plum Solo Precision IV Pump, 40001-0401) and recall number Z-2311-2026, then follow ICU Medical, Inc.'s recall instructions.

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