FDA Enforcement Class I Terminated

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.

Recall: Z-1071-2015 · Reported March 4, 2015

Enforcement

Recall Number
Z-1071-2015
Event ID
69336
Classification
Class I
Status
Terminated
Product Type
Devices
Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 4, 2015
Initiation Date
July 2, 2014
Classification Date
February 23, 2015
Termination Date
May 24, 2017
Address
275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

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

One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.

Code Info

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

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.

Quantity

315 infusion pumps