Plum Duo Infusion System, List Number 40002-04-01
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 15, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | ICU Medical, Inc. |
| Country / region | United States IL |
Hazard
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
Affected products
- Plum Duo Infusion System, List Number 40002-04-01
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