FDA recall Z-2129-2025

ICU Medical, Inc. · Class I · device

Product

Plum Duo Infusion System, List Number: 400020401

Reason for recall

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-07-11
Report date: 2025-08-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2025