Recall Z-1991-2025— ICU Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: ICU Medical Plum Solos, Item number 400011001; infusion pump. Reason: 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..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-22
- Firm location
- Lake Forest, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.