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Recall Observatory FDA recall evidence

Device 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.

Z-1075-2015

July 02, 2014

Class I

Product summary

Firm
Hospira Inc.
Event
Event 69336
Status
Terminated
Classification
Class I
Quantity
190 infusion pumps
Official record key
device-enforcement:Z-1075-2015

Official wording

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 information: 1) List Number:12618: Serial Numbers: 14040926 , 14041563 , 14041565 , 14041611 , 14041627 , 14041901 , 14041912 , 14041921 , 14041953 , 14041960 , 14041964 , 14041973 , 14040654 , 14041065 , 14041554 , 14041604 , 14041606 , 14041621 , 14041902 , 14042270 , 14042280 , 14042475 , 14042477 , 14042495 , 14042514 , 14042524 , 14044012 , 14044024 , 14040142 , 14041107 , 14041800 , 14041989 , 14042077 , 14042462 , 14042490 , 14042499 , 14042502 , 14042820 , 14043029 , 14043312 , 14043750 , 14044015 , 14044018 , 14044025 , 14044028 , 14044055 , 14044448 , 14044459 , 14044467 , 14044469 , 14044472 , 14044481 , 14044497 , 14044507 , 14044510 , 14044689 , 14045142 , 14045145 , 14045161 , 14045175 , 14045181 , 14045520 , 14045758 , 14045789 , 14045995 , 14046010 , 14047080 , 14047113 , 14047181 , 14047217 , 14040140 , 14040196 , 14040459 , 14040626 , 14040628 , 14040744 , 14040976 , 14041070 , 14041095 , 14041248 , 14041270 , 14041349 , 14041616 , 14041785 , 14041869 , 14042152 , 14042267 , 14042637 , 14042784 , 14043035 , 14043385 , 14044035 , 14044449 , 14044452 , 14044457 , 14044461 , 14044468 , 14044490 , 14044495 , 14044496 , 14044498 , 14044500 , 14044502 , 14044503 , 14044506 , 14044514 , 14044518 , 14044539 , 14044577 , 14044896 , 14044909 , 14044993 , 14045120 , 14045176 , 14045177 , 14045186 , 14045952 , 14045976 , 14046019 , 14046154 , 14046698 , 14046700 , 14046781 , 14046822 , 14046827 , 14047258 , 14047805 , 18627447 , 18627450 , 18627451 , 18627452 , 18627455 , 18627459 , 18627460 , 18627461 , 18627462 , 18627464 , 18627466 , 18627467 , 18627475 , 18627490 , 18627495 , 18627502 , 18627505 , 18627508 , 18627554 , 18627572 , 18627573 , 18627607 , 18627704 , 18627710 , 18627711 , 18627714 , 18627715 , 18627720 , 18627725 , 18627731 , 18627732 , 18627733 , 18627761 , 18627762 , 18627765 , 18627766 , 18627767 , 18627783 , 18627784 , 18627787 , 18627870 , 18627872 , 18627876 , 18627882 , 18627891 , 18627917 , 18627928 , 18627935 , 18627939 , 18627942 , 18627944 , 18627945 , 18627946 , 18627952 , 18627954 , 18627956 , 18627961 , 18627962 , 14044492 , 18627449 , 18627610 , 18627938 , 18627953

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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