ICU Medical Plum Solos, Item number 400011001; infusion pump
FDA device recall Z-1991-2025 · posted 2025-06-18 · Open, Classified
Recall details
- Recalling firm
- ICU Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 214 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.
- Date initiated
- 2025-04-22
- Date posted
- 2025-06-18
- Location
- Lake Forest, IL
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