Z-1990-2025Class II

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

Name: Z-1990-2025 ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Creator: ICU Medical, Inc.
Published: 2025-04-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-04-22 / Open, Classified / root cause: software

FDA source

ICU Medical, Inc. began a recall of ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump on 2025-04-22. FDA classified it as Class II and gives the reason as "Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager...". 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-1990-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-22
Posted: 2025-06-18
Recalling firm: Abbott Medical
Product: ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Product code: FRN Pump, Infusion
Reason for recall: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 05/02/2025 via hand delivery. The notice explained the issue, potential risk, and requested the following: Actions for Users: 1. 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. 2. If Maximum Dose Limit is not used for a medication, the issue will not occur. If Maximum Dose Limit is used for a medication, users should take the following precautions. If you need to adjust the weight or BSA, first clear the program and then reprogram. For further inquiries: To report adverse events or product complaints: Global Complaint Management - 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or [email protected]. For any questions regarding this action: Device Correction Inquiries https://icumed.custhelp.com/app/market-action. Additional technical information or assistance: Technical Support 1-(800)-241-4002, option 3 or [email protected].
Quantity in commerce: 1701 units
Distribution: Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
Product codes and lots: 1) 400020401: UDI/DI 400020401, Serial/Lot Numbers: 50000184; UDI/DI +M335400021, Serial/Lot Numbers: 50002748, 50002774, 50001647, 50001654, 50001601, 50001615, 50001651, 50002547, 50002577, 50002678, 50002689, 50002750, 50002751, 50002755, 50002773, 50002788, 50002798, 50002799, 50002801, 50002807, 50002808, 50002818, 50002819, 50002820, 50002821, 50002822, 50002823, 50002824, 50002825, 50002828, 50002832, 50002835, 50002837, 50002839, 50002840, 50002844, 50002845, 50002847, 50002851, 50002853, 50002858, 50002892, 50003000, 50003002, 50003009, 50003023, 50003026, 50003029, 50003033, 50003034, 50003035, 50003036, 50003039, 50003043, 50003045, 50003051, 50003054, 50003058, 50003059, 50003060, 50003062, 50003063, 50003065, 50003087, 50003092, 50003126, 50003143, 50003157, 50003167, 50003201, 50003232, 50003241, 50003244, 50003246, 50003257, 50003259, 50003260, 50003261, 50003262, 50003266, 50003267, 50003268, 50003269, 50003272, 50003274, 50003277, 50003278, 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50002998, 50003003, 50003005, 50003008, 50003010, 50003013, 50003014, 50003073, 50003200; 2) 400021001: UDI/DI 400021001, Serial/Lot Numbers: 50000070; UDI/DI +M335400021, Serial/Lot Numbers: 50000004, 50000005, 50000006, 50000007, 50000008, 50000009, 50000010, 50000011, 50000012, 50000013, 50000014, 50000015, 50000016, 50000017, 50000018, 50000019, 50000020, 50000021, 50000022, 50000023, 50000024, 50000025, 50000026, 50000027, 50000028, 50000029, 50000030, 50000031, 50000032, 50000033, 50000034, 50000035, 50000036, 50000037, 50000038, 50000039, 50000040, 50000041, 50000042, 50000043, 50000044, 50000045, 50000046, 50000047, 50000048, 50000049, 50000050, 50000051, 50000052, 50000053, 50000054, 50000055, 50000056, 50000057, 50000058, 50000059, 50000060, 50000061, 50000062, 50000063, 50000064, 50000065, 50000066, 50000067, 50000068, 50000069, 50000071, 50000072, 50000073, 50000074, 50000075, 50000076, 50000077, 50000078, 50000079, 50000080, 50000081, 50000082, 50000083, 50000084, 50000086, 50000087, 50000088, 50000089, 50000090, 50000091, 50000092, 50000093, 50000094, 50000095, 50000096, 50000097, 50000098, 50000099, 50000100, 50000101, 50000102, 50000103, 50000104, 50000105, 50000106, 50000107, 50000108, 50000109, 50000110, 50000111, 50000112, 50000113, 50000114, 50000115, 50000116, 50000117; 3) 400021003: UDI/DI +M335400021, Serial/Lot Numbers: 80000052, 80000053, 80000054, 80000055, 80000056, 80000057, 80000058, 80000059, 80000060, 80000061, 80000062, 80000063, 80000064, 80000065, 80000066, 80000067, 80000068, 80000069, 80000071, 80000072, 80000073, 80000074, 80000075, 80000076, 80000078, 80000079, 80000080, 80000081, 80000082, 80000083, 80000084, 80000085, 80000086, 80000087, 80000089, 80000090, 80000091, 80000092, 80000093, 80000094, 80000095, 80000096, 80000097, 80000098, 80000099, 80000100, 80000101, 80000102, 80000103, 80000104, 80000024, 80000027, 80000028, 80000030, 80000031, 80000032, 80000034, 80000035, 80000037, 80000038, 80000039, 80000041, 80000042, 80000043, 80000044, 80000045, 80000046, 80000047, 80000048, 80000049, 80000051, 80000001, 80000002, 80000003, 80000006, 80000007, 80000008, 80000009, 80000010, 80000011, 80000012, 80000013, 80000014, 80000015, 80000017, 80000021, 80000022, 80000023, 80000025, 80000026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1990-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1990-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-18
Z-1991-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-18

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)