Z-0206-2014Class II

Plum A+3 Infusion Pump System; List Number: 12348

Name: Z-0206-2014 Plum A+3 Infusion Pump System; List Number: 12348
Creator: Hospira Inc.
Published: 2012-02-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-02-05 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of 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... on 2012-02-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0206-2014
Classification: Class II
Status: Terminated
Initiated: 2012-02-05
Posted: 2013-11-14
Terminated: 2016-11-14
Recalling firm: Abbott Medical
Product: 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
Product code: FRN Pump, Infusion
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira sent an URGENT DEVICE FIELD CORRECTION letter dated February 5, 2013 was sent to all direct accounts notifying them of the issue. For device users who experience these issues, Hospira recommends the following actions be taken: 1) Remove the pump from service and perform a Performance Verification Test (PVT) Distal Occlusion Test to determine if the distal pressure sensor is performing correctly. 2) If the device does not pass the PVT, it may indicate that the distal pressure sensor has drifted. Perform the appropraite troubleshooting and repair activities defined by the user's facility, whihc may include returning the device to Hospira for further diagnosis and servicing. The remediation for this issue is to perform a recalibration of the distal pressure sensor. Hospira also intends to release in 2013 a recommendation of a yearly test to determine if the distal pressure sensor's calibration has drifted. Customers who suspect that their device(s) may be affected by this issue are urged to contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. Hospira will provide loaner devices if necessary. Customers are requested to complete and return the reply form included with the notification letter per the instructions on the reply form. For questions regarding this recall call 224-212-2000.
Quantity in commerce: List No. 12348: 214 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0204-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0205-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0206-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0207-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0208-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0209-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

Product code FRN

K021350Class IIAbbott Plum A+3 Multichannel Infusion Pump, Model 12348Abbott Laboratories / cleared 2002-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)