Class 1 Device Recall The Plum A Infusion System

• Date Initiated by Firm: July 02, 2014
• Date Posted: February 23, 2015
• Recall Status: Terminated on May 24, 2017
• Recall Number: Z-1071-2015
• Recall Event ID: 69336
• 510(K)Number: K011442
• Product Classification: Pump, infusion - Product Code FRN
• 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.
• 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
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Hospira Global Complaint Management; 800-441-4100
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN