FDA recall Z-2724-2026

ICU Medical, Inc. · Class II · device

Product

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

Reason for recall

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2026-06-10
Report date
2026-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2724-2026