Recall Z-2129-2025— ICU Medical, Inc.

Name: FDA recall Z-2129-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Class I · Ongoing

Class I FDA medical device recall by ICU Medical, Inc., initiated 2025-07-11. It names one FDA 510(k) clearance: K223607. Product: Plum Duo Infusion System, List Number: 400020401. Reason: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive..

Recalling firm: ICU Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-07-11
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K223607 — Plum Duo Infusion SystemIcu Medical, Inc.·cleared 2023-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.