ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
FDA Device Recall #Z-1990-2025 — Class II — April 22, 2025
Recall Summary
| Recall Number | Z-1990-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ICU Medical, Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | 1701 units |
Product Description
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
Lot / Code Information
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, 50003279, 50003280, 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50000136, 50000137, 50000138, 50000139, 50000140, 50000141, 50000142, 50000143, 50000144, 50000145, 50000146, 50000147, 50000148, 50000149, 50000150, 50000151, 50000152, 50000153, 50000154, 50000155, 50000156, 50000157, 50000158, 50000159, 50000160, 50000161, 50000162, 50000163, 50000164, 50000165, 50000166, 50000167, 50000168, 50000169, 50000170, 50000171, 50000172, 50000173, 50000174, 50000175, 50000176, 50000177, 50000178, 50000179, 50000180, 50000181, 50000182, 50000183, 50000185, 50000186, 50000187, 50000188, 50000189, 50000190, 50000191, 50000192, 50000193, 50000194, 50000195, 50000196, 50000197, 50000198, 50000199, 50000200, 50000201, 50000202, 50000203, 50000204, 50000205, 50000206, 50000207, 50000208, 50000209, 50000210, 50000211, 50000212, 50000213, 50000214, 50000215, 50000216, 50000217, 50000218, 50000219, 50000220, 50000222, 50000223, 50000224, 50000225, 50000226, 50000227, 50000228, 50000229, 50000230, 50000231, 50000232, 50000233, 50000234, 50000235, 50000236, 50000237, 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50003899, 50003900, 50003901, 50003902, 50003903, 50003905, 50003906, 50003908, 50003911, 50003912, 50003913, 50003914, 50003916, 50003917, 50003918, 50003919, 50003920, 50003922, 50003923, 50003925, 50003926, 50003927, 50003929, 50003931, 50003934, 50003936, 50003938, 50003940, 50003942, 50003944, 50003945, 50003946, 50003947, 50003948, 50003951, 50003952, 50003953, 50003954, 50003955, 50003956, 50003957, 50003959, 50003960, 50003961, 50003962, 50003963, 50003964, 50003965, 50003966, 50003968, 50003970, 50003971, 50003972, 50003976, 50003977, 50003981, 50003984, 50003985, 50003986, 50003987, 50003989, 50003991, 50003993, 50003994, 50003996, 50003999, 50004001, 50004002, 50004003, 50004004, 50004005, 50004007, 50004008, 50004009, 50004010, 50004011, 50004012, 50004013, 50004014, 50004017, 50004018, 50004019, 50004021, 50004022, 50004024, 50004026, 50004028, 50004029, 50004030, 50004031, 50004032, 50004033, 50004034, 50004035, 50004036, 50004037, 50004038, 50004039, 50004041, 50004042, 50004043, 50004044, 50004045, 50004047, 50004049, 50004050, 50004051, 50004052, 50004053, 50004054, 50004055, 50004056, 50004057, 50004058, 50004059, 50004061, 50004062, 50004063, 50004064, 50004065, 50004067, 50004068, 50004069, 50004071, 50004073, 50004075, 50004076, 50004080, 50004081, 50004082, 50004084, 50004085, 50004086, 50004087, 50004088, 50004089, 50004090, 50004091, 50004092, 50004093, 50004095, 50004096, 50004097, 50004098, 50004101, 50004102, 50004103, 50004104, 50004109, 50004110, 50004112, 50004113, 50004114, 50004115, 50004116, 50004117, 50004118, 50004119, 50004122, 50004123, 50004126, 50004127, 50004129, 50004130, 50004131, 50004134, 50004135, 50004137, 50004138, 50004139, 50004140, 50004142, 50004143, 50004145, 50004147, 50004151, 50004152, 50004153, 50004155, 50004159, 50004162, 50004164, 50004165, 50004169, 50004170, 50004171, 50004172, 50004173, 50004174, 50004175, 50004176, 50004180, 50004186, 50004187, 50004190, 50004192, 50004195, 50004196, 50004199, 50004215, 50004221, 50004231, 50004233, 50004238, 50004239, 50001392, 50001415, 50001427, 50001439, 50001440, 50001448, 50001458, 50001461, 50001474, 50001482, 50001501, 50001505, 50001510, 50001536, 50001544, 50001558, 50001559, 50001562, 50001563, 50001565, 50001574, 50001576, 50001593, 50001600, 50001631, 50002514, 50002575, 50002623, 50002629, 50002646, 50002677, 50002692, 50002722, 50002726, 50002735, 50002742, 50002764, 50002817, 50003004, 50000294, 50000295, 50000296, 50000298, 50000299, 50000303, 50000304, 50000309, 50001694, 50001714, 50001723, 50001739, 50001788, 50001795, 50001812, 50001813, 50001815, 50001818, 50001819, 50001831, 50001840, 50001842, 50001849, 50001859, 50001866, 50001869, 50001871, 50001874, 50001875, 50001876, 50001878, 50001879, 50001884, 50001885, 50001889, 50001892, 50001894, 50001895, 50001899, 50001900, 50001902, 50001903, 50001904, 50001905, 50001906, 50001907, 50001911, 50001920, 50001923, 50001924, 50001925, 50001928, 50001929, 50001930, 50001934, 50001935, 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50002867, 50002868, 50002869, 50002870, 50002871, 50002872, 50002875, 50002877, 50002879, 50002880, 50002881, 50002882, 50002883, 50002884, 50002885, 50002886, 50002887, 50002888, 50002890, 50002891, 50002893, 50002894, 50002895, 50002898, 50002899, 50002900, 50002901, 50002902, 50002903, 50002904, 50002905, 50002906, 50002907, 50002908, 50002909, 50002910, 50002911, 50002913, 50002914, 50002915, 50002916, 50002917, 50002918, 50002919, 50002921, 50002923, 50002924, 50002925, 50002926, 50002927, 50002928, 50002929, 50002930, 50002932, 50002933, 50002934, 50002935, 50002936, 50002937, 50002939, 50002940, 50002942, 50002944, 50002947, 50002948, 50002949, 50002950, 50002951, 50002956, 50002958, 50002960, 50002961, 50002962, 50002963, 50002964, 50002965, 50002966, 50002967, 50002968, 50002969, 50002970, 50002971, 50002972, 50002976, 50002977, 50002978, 50002979, 50002980, 50002981, 50002982, 50002986, 50002987, 50002988, 50002989, 50002991, 50002993, 50002994, 50002996, 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.
Other Recalls from ICU Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1111-2026 | Class II | Tego Connector: REF: 011-D1000, 01C-D1000, 055-... | Dec 19, 2025 |
| Z-1094-2026 | Class II | Plum Duo Infusion System, List Number 40002-04-01 | Dec 15, 2025 |
| Z-1119-2026 | Class II | ICU Medical Plum Duo Precision IV Pump, List Nu... | Dec 15, 2025 |
| Z-1120-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, List N... | Dec 15, 2025 |
| Z-1118-2026 | Class II | ICU Medical Plum Duo Infusion Pump, List Number... | Dec 15, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.