FDA Medical devices recall ·
Allegedly counterfeit batteries manufactured by CSB batteries being used… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0482-2025
- Date
- (initiated October 22, 2024)
- Company / brand
- ICU Medical, Inc.
600 N Field Dr, Lake Forest, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3840
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
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 Kingdom, and Uruguay.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0482-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.