Counterfeit Batteries (ICU Medical) – Battery Authenticity (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx
Products Sold
All batteries WITHOUT the following information on the label: 1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery): W2401xxxx - W2406xxx
ICU Medical, Inc. is recalling Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: due to ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visua. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026