BEUDAMED
    FDA Enforcement Class II Terminated

    Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

    Recall: Z-0206-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0206-2014
    Event ID
    64091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    February 5, 2012
    Classification Date
    November 14, 2013
    Termination Date
    November 14, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

    Reason

    Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not

    Code Info

    List No. 12348; Serial Numbers: 13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 13740890 , 13740891 , 13740892 , 13740893 , 13740894 , 13740895 , 13740896 , 13740897 , 13740898 , 13740899 , 13740900 , 13740901 , 13740902 , 13740903 , 13740904 , 13740905 , 13740906 , 13740907 , 13740908 , 13740909 , 13740910 , 13740911 , 13740912 , 13740913 , 13740914 , 13740915 , 13740916 , 13740917 , 13740918 , 13740919 , 13740920 , 13740921 , 13740922 , 13740923 , 13740924 , 13740925 , 13740926 , 13740927 , 13740928 , 13740929 , 13740930 , 13740977 , 13740980 , 13740982 , 13740986 , 13740994 , 13741025

    Distribution

    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.

    Quantity

    List No. 12348: 214 units