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.
- Company
- Hospira Inc.
- Recall Initiated
- July 2, 2014
- Posted
- February 23, 2015
- Terminated
- May 24, 2017
- Recall Number
- Z-1071-2015
- Quantity
- 315 infusion pumps
- Firm Location
- Lake Forest, IL
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
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.
Lot / 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
Root Cause
Component change control
Action Taken
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.