FDA DevicesClass II
Plum Duo Infusion System, List Number 40002-04-01
Published: January 21, 2026Recall ID: Z-1094-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Plum Duo Infusion System, List Number 40002-04-01
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Forest |
| State | IL |
| Event id | 98129 |
| Address 1 | 600 N Field Dr |
| Code info | UDI-DI: M335400021; Serial Numbers: 50000221 50000294 50000295 50000296 50000298 50000299 50000300 50000303 50000304 50000309 50001663 50001664 50001665 50001666 50001667 50001668 50001669 50001670 50001671 50001672 50001673 50001674 50001675 50001676 50001677 50001678 50001679 50001680 50001681 50001682 50001683 50001684 50001685 50001686 50001687 50001688 50001689 50001690 50001691 50001692 50001693 50001694 50001695 50001696 50001697 50001698 50001699 50001700 50001701 50001702 50001703 50001704 50001705 50001706 50001707 50001708 50001709 50001710 50001711 50001712 50001713 50001714 50001715 50001716 50001717 50001718 50001719 50001720 50001721 50001722 50001723 50001724 50001725 50001726 50001727 50001728 50001729 50001730 50001731 50001732 50001733 50001734 50001735 50001736 50001737 50001738 50001739 50001740 50001741 50001742 50001743 50001744 50001745 50001746 50001747 50001748 50001749 50001750 50001751 50001752 50001753 50001754 50001755 50001756 50001757 50001758 50001759 5... [TRUNCATED] |
| Postal code | 60045-4835 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 423 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260115 |
Overview
- Recalling FirmICU Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.