ICU Medical, Inc.: Device Recall

Recall #Z-2129-2025 · 07/11/2025

Class I: Dangerous

Recall Details

Recall Number: Z-2129-2025
Classification: Class I
Product Type: Device
Recalling Firm: ICU Medical, Inc.
Status: Ongoing
Date Initiated: 07/11/2025
Location: Lake Forest, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4677 units

Reason for Recall

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

Product Description

Plum Duo Infusion System, List Number: 400020401

Distribution Pattern

US Nationwide.

Other Recalls by ICU Medical, Inc.

Class II: Risk 12/19/2025

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Class II: Risk 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/15/2025

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Class II: Risk 12/15/2025

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

View all recalls by ICU Medical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.