Z-0286-2014Class II

The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and...

Name: Z-0286-2014 The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and...
Creator: Hospira Inc.
Published: 2013-02-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-02-01 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard... on 2013-02-01. FDA classified it as Class II and gives the reason as "Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0286-2014
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2013-11-14
Terminated: 2016-12-06
Recalling firm: Abbott Medical
Product: The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Product code: FRN Pump, Infusion
Reason for recall: Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
Root cause tag: design
FDA root cause: Component design/selection
Action: Hospira sent an Urgent Device Field Correction letter dated February 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter recommends that facilities immediately visually inspect their Plum a+ devices to determine if the distal pressure pin is broken or damaged via instructions included in the letter. If a broken or damaged distal pressure pin is observed, remove the device from service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to report the issue. If the return of defective pumps significantly impairs a facility's ability to operate normally, Hospira will provide loaner pumps. The letter also encourages customers to insert cassettes into pumps in accordance with the instructions found in the operator's manual. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to call 1-800-441-4100 or 1-800-241-4002, option 4. The letter also asked direct accounts that further distributed the pumps notify their customers of the URGENT DEVICE FIELD CORRECTION and ask them to contact Stericycle at 1-866-201-9068 to receive a reply form.. For questions regarding this recall call 800-441-4100,
Quantity in commerce: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
Product codes and lots: 1) List Number 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-0286-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0284-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0285-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0286-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0287-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0288-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0289-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0290-2014	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)