Z-2311-2026Class II

Plum Solo Precision IV Pump, 40001-0401

Name: Z-2311-2026 Plum Solo Precision IV Pump, 40001-0401
Creator: ICU Medical, Inc.
Published: 2026-04-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-04-29 / Open, Classified / root cause: software

FDA source

ICU Medical, Inc. began a recall of Plum Solo Precision IV Pump, 40001-0401 on 2026-04-29. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2311-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-29
Posted: 2026-06-05
Recalling firm: Abbott Medical
Product: Plum Solo Precision IV Pump, 40001-0401
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On April 29, 2026, the firm notified consignees via letters titled "URGEND MEDICAL DEVICE CORRECTION." Customers were instructed to identify all affected pumps in their possession and ensure all users or potential users of the pumps are immediately made aware of the notification. During bolus programming, clinicians should check whether the soft limit override icon is displayed next to the bolus dose entry field on the programming screen. If the pump displays the icon, the clinician should review the program and make any necessary adjustments before confirming the program. The firm is developing a software update to correct the issue and will notify customers when it is available.
Quantity in commerce: 13,613
Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Product codes and lots: UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2311-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2311-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2312-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2313-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code FRN

K242114Class IIPlum Solo™ Precision IV PumpIcu Medical, Inc. / cleared 2025-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)