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U.S. Department of Health and Human Services

Class 2 Device Recall ICU Medical Plum

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 Class 2 Device Recall ICU Medical Plumsee related information
Date Initiated by FirmApril 22, 2025
Date PostedJune 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1991-2025
Recall Event ID 96777
Product Classification Pump, infusion - Product Code FRN
ProductICU Medical Plum Solos, Item number 400011001; infusion pump
Code Information UDI/DI N/A, Serial/Lot Numbers: 60000001, 60000002, 60000003, 60000005, 60000006, 60000007, 60000008, 60000009, 60000010, 60000011, 60000014, 60000015, 60000016, 60000017, 60000019, 60000020, 60000021, 60000023, 60000024, 60000025, 60000026, 60000027, 60000028, 60000030, 60000032, 60000033, 60000035, 60000038, 60000039, 60000040, 60000041, 60000042, 60000044, 60000045, 60000046, 60000047, 60000048, 60000049, 60000050, 60000051, 60000052, 60000053, 60000054, 60000056, 60000057, 60000058, 60000059, 60000060, 60000061, 60000062, 60000063, 60000064, 60000065, 60000066, 60000067, 60000068, 60000069, 60000070, 60000071, 60000072, 60000073, 60000074, 60000075, 60000076, 60000077, 60000078, 60000079, 60000080, 60000081, 60000082, 60000083, 60000084, 60000085, 60000087, 60000088, 60000089, 60000090, 60000092, 60000093, 60000094, 60000095, 60000096, 60000097, 60000098, 60000099, 60000100, 60000101, 60000102, 60000104, 60000105, 60000107, 60000108, 60000109, 60000110, 60000112, 60000113, 60000114, 60000120, 60000130, 60000133, 60000134, 60000136, 60000139, 60000141, 60000143, 60000147, 60000150, 60000154, 60000159, 60000160, 60000162, 60000165, 60000167, 60000170, 60000171, 60000172, 60000173, 60000174, 60000176, 60000177, 60000178, 60000179, 60000180, 60000183, 60000187, 60000189, 60000190, 60000191, 60000192, 60000198, 60000199, 60000201, 60000203, 60000204, 60000205, 60000206, 60000207, 60000208, 60000209, 60000210, 60000212, 60000213, 60000214, 60000215, 60000216, 60000217, 60000223, 60000224, 60000225, 60000226, 60000227, 60000228, 60000229, 60000230, 60000234, 60000236, 60000237, 60000238, 60000239, 60000240, 60000241, 60000242, 60000244, 60000245, 60000246, 60000247, 60000249, 60000251, 60000252, 60000255, 60000257, 60000259, 60000263, 60000264, 60000265, 60000266, 60000268, 60000269, 60000271, 60000273, 60000274, 60000275, 60000276, 60000277, 60000279, 60000280, 60000281, 60000282, 60000283, 60000284, 60000285, 60000286, 60000288, 60000291, 60000292, 60000295, 60000296, 60000297, 60000298, 60000300, 60000155, 60000193, 60000197, 60000211, 60000243, 60000270, 60000272, 60000123, 60000168, 60000175, 60000195, 60000221, 60000256, 60000294.
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactTechnical Support
800-241-4002 Ext. 3
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionICU 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.
Quantity in Commerce214 units
DistributionWorldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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