Recall Z-0482-2025 ยท FRN Pump, Infusion
ICU Medical, Inc.
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
| Date | Nov 21, 2024 (initiated Oct 22, 2024) |
| Status | Open, Classified |
| 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 Medic |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.