# FDA recall Z-0482-2025

> **ICU Medical, Inc.** · Class I · device recall initiated 2024-10-22.

## 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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0482-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-22
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2025

## Citation

> AI Analytics. FDA recall Z-0482-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0482-2025. Source: US FDA. Licensed CC0.

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