Z-1071-2015Class I

The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving...

Name: Z-1071-2015 The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving...
Creator: Hospira Inc.
Published: 2014-07-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-07-02 / Terminated

FDA source

Hospira Inc. began a recall of The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based... on 2014-07-02. FDA classified it as Class I and gives the reason as "One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1071-2015
Classification: Class I
Status: Terminated
Initiated: 2014-07-02
Posted: 2015-02-23
Terminated: 2017-05-24
Recalling firm: Abbott Medical
Product: The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.
Product code: FRN Pump, Infusion
Reason for recall: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
FDA root cause: Component change control
Action: Hospira sent an Urgent Medical Device Correction letter dated July 2, 2014, to all affected customers. The letter notified customers that Hospira will be contacting them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test. Additionally, the letter included instructions for customers to: 1) inform potential users of this notification; 2) complete and return the attached reply form; and, 3) if the products were further distributed, notify those accounts of this recall and ask them to contact Stericycle at 888-912-7350 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. A second URGENT MEDICAL DEVICE CORRECTION letter dated July 16, 2014 was sent to all customers of record because the initial letters may have contained errors in the attached data files listing the potentially affected devices at the customer's' facility. The instructions to the customer were unchanged from the original letter. For questions regarding this recall call 800-441-4100.
Quantity in commerce: 315 infusion pumps
Distribution: Worldwide Distribution - USA including AK, AL, AR, 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 Brazil, Canada, Colombia, Ecuador, France, Israel, Italy, Mexico, Oman, Peru, Saudi Arabia, Spain, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: 1) List Number: 11971; Serial Numbers: 13133156 , 13122435 , 13128432 , 13130874 , 13131209 , 13131250 , 13131390 , 13131491 , 13132778 , 13132853 , 13133527 , 13133774 , 13134952 , 13135262 , 13136844 , 13136851 , 13136858 , 13136859 , 13136867 , 13136875 , 13138072 , 13138108 , 13138378 , 13138416 , 13138430 , 13138457 , 13138522 , 13138527 , 13138529 , 13138553 , 13138584 , 13138595 , 13138603 , 13138624 , 13138632 , 13138637 , 13138638 , 13138641 , 13138654 , 13138655 , 13138667 , 13138672 , 13138678 , 13138679 , 13138690 , 13138699 , 13138701 , 13138714 , 13138727 , 13138729 , 13138740 , 13138754 , 13138755 , 13138764 , 13138765 , 13138769 , 13138780 , 13138781 , 13138788 , 13138794 , 13138799 , 13138814 , 13138824 , 13138841 , 13138843 , 13138853 , 13138876 , 13138877 , 13139028 , 13139227 , 13139339 , 13139391 , 13139395 , 13139404 , 13139414 , 13139434 , 13139488 , 13139489 , 13139495 , 13139499 , 13139502 , 13139510 , 13139513 , 13139519 , 13139526 , 13139537 , 13139539 , 13139540 , 13139542 , 13139545 , 13139546 , 13139547 , 13139548 , 13139549 , 13139552 , 13139560 , 13139561 , 13139563 , 13139566 , 13139572 , 13139575 , 13139576 , 13139578 , 13139579 , 13139580 , 13139585 , 13139586 , 13139588 , 13139590 , 13139591 , 13139594 , 13139600 , 13139608 , 13139610 , 13139612 , 13139613 , 13139617 , 13139623 , 13139624 , 13139625 , 13139627 , 13139628 , 13139630 , 13139633 , 13139635 , 13139636 , 13139640 , 13139642 , 13139643 , 13139644 , 13139645 , 13139649 , 13139650 , 13139655 , 13139657 , 13139658 , 13139659 , 13139667 , 13139668 , 13139669 , 13139670 , 13139671 , 13139672 , 13139673 , 13139674 , 13139675 , 13139679 , 13139681 , 13139683 , 13139686 , 13139687 , 13139690 , 13139694 , 13139695 , 13139696 , 13139697 , 13139703 , 13139705 , 13139710 , 13139711 , 13139714 , 13139715 , 13139716 , 13139718 , 13139720 , 13139721 , 13139723 , 13139727 , 13139728 , 13139729 , 13139731 , 13139732 , 13139734 , 13139735 , 13139737 , 13139739 , 13139742 , 13139745 , 13139749 , 13139750 , 13139752 , 13139753 , 13139754 , 13139756 , 13139761 , 13139763 , 13139765 , 13139766 , 13139767 , 13139771 , 13139773 , 13139774 , 13139775 , 13139776 , 13139777 , 13139780 , 13139785 , 13139790 , 13139792 , 13139793 , 13139798 , 13139816 , 13139827 , 13139829 , 13139830 , 13139831 , 13139840 , 13139842 , 13139845 , 13139846 , 13139847 , 13139853 , 13139855 , 13139863 , 13139864 , 13139866 , 13139869 , 13139870 , 13139874 , 13139879 , 13139880 , 13139897 , 13139899 , 13139902 , 13139905 , 13139907 , 13139909 , 13139910 , 13139911 , 13139913 , 13139915 , 13139925 , 13139926 , 13139927 , 13139932 , 13139933 , 13139934 , 13139936 , 13139937 , 13139943 , 13139947 , 13139949 , 13139950 , 13139957 , 13139959 , 13139962 , 13139963 , 13139968 , 13139975 , 13139976 , 13139979 , 13139980 , 13139982 , 13139983 , 13139984 , 13139985 , 13140020 , 13140032 , 13140110 , 13141120 , 13141399 , 13142413 , 13142655 , 13142707 , 13142826 , 13130020 , 13134735 , 13138720 , 13139595 , 13139620 , 13139948 , 13140036 , 13142585 , 13142614 , 13142615 , 13211168 , 13211642 , 13120565 , 13122992 , 13128976 , 13129513 , 13130972 , 13133575 , 13135437 , 13137740 , 13138237 , 13139104 , 13139114 , 13139365 , 13139648 , 13140625 , 13142468 , 13142689 , 13211134 , 13211248 , 13211509 , 13211671 , 13212053 , 13212120 , 13212125 , 13120502 , 13121671 , 13126679 , 13126891 , 13127203 , 13129908 , 13131099 , 13131674 , 13134328 , 13138812 , 13140759 , 13142444 , 13143595 , 13144347 , 13210041

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23
Z-1072-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23
Z-1073-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23
Z-1074-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23
Z-1075-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23

Product code FRN

K011442Class IIAbbott Plum A+infusion Pump, Model 11971Abbott Laboratories / cleared 2001-06-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)