Z-2311-2026 Class II Ongoing

Recalled by ICU Medical, Inc. — Lake Forest, IL

Recall Details

Product Type
Devices
Report Date
June 17, 2026
Initiation Date
April 29, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,613

Product Description

Plum Solo Precision IV Pump, 40001-0401

Reason for Recall

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

Code Information

UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3