Z-1118-2026Class II

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

Name: Z-1118-2026 ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Creator: ICU Medical, Inc.
Published: 2025-12-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-12-15 / Open, Classified / root cause: software

FDA source

ICU Medical, Inc. began a recall of ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) on 2025-12-15. FDA classified it as Class II and gives the reason as "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...". 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-1118-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-01-16
Recalling firm: Abbott Medical
Product: ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/15/2025 via mail, email, telephone, or hand delivery. The notice explained the issue, potential risk and requested the following: "Actions for Users Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and the sequence of events described. If you do experience this issue, the following mitigations can be performed: " To program the piggyback flush, the clinician must either a) clear infusion program data and power cycle the pump or b) obtain a replacement pump. " The clinician may also continue with the piggyback infusion without using the piggyback flush feature. To manually flush the downstream line, attach and program a flush syringe or bag on Line 2 to flush the fluid from the downstream line at the piggyback rate before restarting the primary line." For device correction inquiries, contact https://icumed.custhelp.com/app/market-action. For technical support, contact: 1-(800)-241-4002, option 3; [email protected]. For complaints, contact: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or [email protected].
Distribution: Worldwide distribution - US Nationwide and the country of Philippines.
Product codes and lots: 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1119-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1120-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16

Product code FRN

K223607Class IIPlum Duo™ Infusion SystemIcu Medical, Inc. / cleared 2023-08-24

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)