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.
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. Distribution: Worldwide - US Nationwide distribution. Quantity: 423 units Lot/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 50001760 50001761 50001762 50001763 50001765 50001766 50001768 50001770 50001771 50001772 50001773 50001774 50001775 50001776 50001777 50001778 50001779 50001780 50001781 50001782 50001783 50001784 50001785 50001786 50001787 50001788 50001789 50001790 50001791 50001792 50001793 50001794 50001795 50001796 50001797 50001798 50001799 50001800 50001801 50001802 50001803 50001804 50001805 50001806 50001807 50001809 50001810 50001811 50001812 50001813 50001814 50001815 50001816 50001817 50001818 500018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.