ICU Medical Plum Solos, Item number 400011001; infusion pump
Reported: June 25, 2025 Initiated: April 22, 2025 #Z-1991-2025
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units 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.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
ICU Medical Plum Solos, Item number 400011001; infusion pump. Recalled by ICU Medical, Inc.. Units affected: 214 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1991-2025.
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