Z-1071-2015 Class I Terminated
FDA device recall Z-1071-2015 was initiated by Hospira Inc. on Jul 2, 2014 and is designated Class I. 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. The recall status is terminated (terminated May 24, 2017). Affected quantity: 315 infusion pumps.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2015
- Initiation Date
- Jul 2, 2014
- Termination Date
- May 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315 infusion pumps
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1071-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026