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RecallWatchMedical Device Safety
Class IIOngoingZ-1990-2025

ICU Medical, Inc. recalls ICU Medical Plum Duo

ICU Medical, Inc.Lake Forest, IL, United StatesReported Jun 25, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Lot #
50000184; UDI/DI +M335400021, Serial/
Lot #
50002748, 50002774, 50001647, 50001654, 50001601, 50001615 — +1491 moreShow all
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, 50003281, 50003282, 50003285, 50003286, 50003287, 50003288, 50003290, 50003291, 50003292, 50003293, 50003298, 50003299, 50003300, 50003301, 50003302, 50003305, 50003307, 50003308, 50003309, 50003311, 50003312, 50003316, 50003317, 50003319, 50003329, 50003331, 50003334, 50003335, 50003339, 50003340, 50003343, 50003345, 50003352, 50003360, 50003403, 50003415, 50003431, 50003433, 50003456, 50003460, 50003485, 50003492, 50003497, 50003498, 50003500, 50003514, 50003524, 50003548, 50003575, 50003603, 50003604, 50003615, 50003617, 50003689, 50003690, 50003702, 50003716, 50003736, 50003754, 50003757, 50003779, 50003826, 50003830, 50003835, 50003862, 50003867, 50003873, 50003874, 50003883, 50003937, 50003950, 50003958, 50003975, 50003982, 50003983, 50003988, 50003990, 50003992, 50003995, 50004006, 50004023, 50004074, 50004077, 50004099, 50004106, 50004121, 50004125, 50004136, 50000124, 50000125, 50000126, 50000127, 50000128, 50000129, 50000130, 50000131, 50000132, 50000133, 50000134, 50000135, 50000136, 50000137, 50000138, 50000139, 50000140, 50000141, 50000142, 50000143, 50000144, 50000145, 50000146, 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50002239, 50002251, 50002280, 50002281, 50002290, 50002292, 50002293, 50002294, 50002296, 50002297, 50002298, 50002301, 50002302, 50002311, 50001567, 50001612, 50001658, 50002836, 50002873, 50002938, 50002974, 50002975, 50002992, 50002995, 50002997, 50003001, 50003006, 50003007, 50003011, 50003012, 50003016, 50003017, 50003019, 50003020, 50003021, 50003022, 50003024, 50003025, 50003027, 50003038, 50003040, 50003053, 50003064, 50003067, 50003068, 50003074, 50003078, 50002736, 50002990, 50003037, 50003103, 50003131, 50003136, 50003145, 50003146, 50003152, 50003153, 50003155, 50003156, 50003158, 50003162, 50003163, 50003165, 50003171, 50003173, 50003176, 50003177, 50003178, 50003188, 50003189, 50003190, 50003192, 50003193, 50003194, 50003195, 50003197, 50003198, 50003199, 50003203, 50003206, 50003208, 50003209, 50003214, 50003217, 50003218, 50003423, 50003440, 50003455, 50003509, 50003518, 50003534, 50003545, 50003585, 50003605, 50003625, 50003631, 50003645, 50003648, 50003796, 50002876, 50002897, 50003018, 50003028, 50003030, 50003032, 50003044, 50003048, 50003057, 50003070, 50003071, 50003076, 50003077, 50003079, 50003080, 50003083, 50003084, 50003085, 50003088, 50003093, 50003094, 50003095, 50003098, 50003100, 50003101, 50003102, 50003104, 50003105, 50003106, 50003107, 50003108, 50003109, 50003110, 50003111, 50003112, 50003114, 50003115, 50003116, 50003117, 50003118, 50003119, 50003120, 50003121, 50003122, 50003123, 50003124, 50003125, 50003127, 50003128, 50003129, 50003130, 50003132, 50003133, 50003134, 50003135, 50003137, 50003138, 50003139, 50003140, 50003141, 50003142, 50003144, 50003148, 50003149, 50003151, 50003154, 50003159, 50003161, 50003166, 50003168, 50003170, 50003172, 50003175, 50003179, 50003181, 50003182, 50003183, 50003184, 50003185, 50003186, 50003187, 50003191, 50003196, 50003202, 50003205, 50003207, 50003211, 50003212, 50003215, 50003216, 50003219, 50003220, 50003221, 50003222, 50003223, 50003224, 50003225, 50003226, 50003227, 50003228, 50003229, 50003230, 50003231, 50003233, 50003234, 50003235, 50003236, 50003238, 50003239, 50003240, 50003242, 50003243, 50003245, 50003247, 50003248, 50003249, 50003250, 50003251, 50003252, 50003253, 50003254, 50003255, 50003256, 50003258, 50003263, 50003264, 50003265, 50003270, 50003271, 50003273, 50003276, 50003283, 50003284, 50003295, 50003296, 50003297, 50003303, 50003304, 50003306, 50003310, 50003313, 50003314, 50003315, 50003318, 50003320, 50003321, 50003322, 50003323, 50003324, 50003325, 50003326, 50003328, 50003330, 50003332, 50003333, 50003336, 50003337, 50003342, 50003346, 50003349, 50003350, 50003351, 50003353, 50003354, 50003355, 50003356, 50003357, 50003359, 50003361, 50003365, 50003366, 50003367, 50003368, 50003369, 50003370, 50003371, 50003372, 50003373, 50003374, 50003375, 50003377, 50003378, 50003379, 50003380, 50003381, 50003383, 50003385, 50003386, 50003387, 50003388, 50003389, 50003390, 50003392, 50003394, 50003395, 50003396, 50003397, 50003398, 50003399, 50003401, 50003402, …
Lot #
50000070; UDI/DI +M335400021, Serial/
Lot #
50000004, 50000005, 50000006, 50000007, 50000008, 50000009 — +107 moreShow all
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 #
80000052, 80000053, 80000054, 80000055, 80000056, 80000057 — +84 moreShow all
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

What the firm is doing

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 ProductComplaintsPP@icumed.com. 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 tsc.support@icumed.com.

DistributionShow details

Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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