ICU Medical Plum Solos, Item number 400011001; infusion pump

Recall Insight

This FDA Devices action (record #Z-1991-2025) was formally reported on June 25, 2025, with the manufacturer initiating the action on April 22, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. ICU Medical, Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records indicate 214 units units are affected.

The documented reason for this recall is: 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 (DL… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.