FDA Medical devices recall ·
ICU Medical Plum Solos, Item number 400011001 recall
- Recall number
- Z-1991-2025
- Date
- (initiated April 22, 2025)
- Company / brand
- ICU Medical, Inc.
600 N Field Dr, Lake Forest, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 214 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
States: California Florida Iowa Kentucky Massachusetts Mississippi New York Pennsylvania Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1991-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.