ICU Medical is recalling some CSB batteries that are intended for use with Plum 360, Plum A+, and Plum A+3 Infusion Systems after receiving reports of the allegedly counterfeit batteries being used with infusion pumps. These batteries have not been tested or validated for use with the systems. Preliminary reports suggest that the batteries fail to hold charge and the pump may display battery replacement messages earlier than expected.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. should report adverse events or product complaints to Global Complaint Management: 1-844-654-7780 or ProductComplaintsPP@icumed.com. For additional information or other assistance, contact Technical Assistance, 1-800-241-4002, option 3.