Recall Z-0482-2025— ICU Medical, Inc.

Class I FDA medical device recall by ICU Medical, Inc., initiated 2024-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197. Reason: ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical..

Recalling firm

ICU Medical, Inc.

Classification

Class I

Status

Ongoing

Initiated

2024-10-22

Firm location

Lake Forest, IL, United States

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