Z-1991-2025 Class II Ongoing
FDA device recall Z-1991-2025 was initiated by ICU Medical, Inc. on April 22, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 214 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2025
- Initiation Date
- April 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 214 units
Product Description
ICU Medical Plum Solos, Item number 400011001; 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.
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.