# FDA recall Z-1565-2023

> **ICU Medical Inc** · Class I · device recall initiated 2023-03-22.

## Product

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

## Reason for recall

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-1565-2023
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-22
- **Report date:** 2023-05-24

- **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-1565-2023

## Citation

> AI Analytics. FDA recall Z-1565-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1565-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*