Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion

FDA device recall Z-0482-2025 · posted 2024-11-21 · Open, Classified

Recall details

Recalling firm

ICU Medical, Inc.

Reason for recall

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.

Action taken

ICU Medical issued an "URGENT MEDICAL DEVICE SAFETY ALERT" on 10/22/2024 via letter. The notice explained the issue, potential risk of use, and requested that all affected products be removed from use and destroyed. Distributors were directed to forward the notice to their customers. For further inquiries: Additional information or technical assistance: Technical Support, 1-800-241-4002 (M-F, 8:00 am 6:00 pm CT); To report adverse events or product complaints: Global Complaint Management, 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or ProductComplaintsPP@icumed.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FRN

Quantity affected

3840

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexi

Date initiated

2024-10-22

Date posted

2024-11-21

Location

Lake Forest, IL