FDAFDA · Food and drugs·Recall number Z-0290-2014
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Published November 20, 2013 · Recall initiated: February 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, 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 U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
- Lot
- *** 1) List Number 20679; Serial Numbers: 15441019 , 15441020 , 15441037 , 15441044 , 15441082 , 15441093 , 15441118 , 15441226 , 15441229 , 15441230 , 15441240 , 15441241 , 15441244 , 15441246 , 15441247 , 15441249 , 15441253 , 15441256 , 15441258 , 15441260 , 15441265 , 15441266 , 15441270 , 15441271 , 15441272 , 15441275 , 15441285 , 15441303 , 15441304 , 15441315 , 15441318 , 15441321 , 15441323 , 15441325 , 15441349 , 15441350 , 15441367 , 15441369 , 15441371 , 15441372 , 15441378 , 15441395 , 15441399 , 15441405 , 15441409 , 15441411 , 15441437 , 15441458 , 15441489 , 15441492 , 15441493 , 15441502 , 15441506 , 15441508 , 15441513 , 15441515 , 15441516 , 15441520 , 15441522 , 15441524 , 15441526 , 15441528 , 15441532 , 15441533 , 15441534 , 15441535 , 15441536 , 15441554 , 15441601 , 15441604 , 15441605 , 15441610 , 15441611 , 15441615 , 15441633 , 15441637 , 15441638 , 15441649 , 15441704 , 15441765 , 15441816 , 15441839 , 15441960 , 15441966 , 15442037 , 15442062 , 15442090 , 15442124 , 15442126 , 15442157 , 15442193 , 15442197 , 15442207 , 15442235 , 15442280 , 15442304 , 15442306 , 15442327 , 15442370 , 15442401 , 15442408 , 15442417 , 15442448 , 15442457 , 15442512 , 15442544 , 15442636 , 15442663 , 15442831 , 15442838 , 15442841 , 15442893 , 15442905 , 15442920 , 15442927 , 15442961 , 15442974 , 15442979 , 15442998 , 15443001 , 15443003 , 15443005 , 15443006 , 15443007 , 15443008 , 15443010 , 15443018 , 15443023 , 15443025 , 15443027 , 15443028 , 15443030 , 15443031 , 15443033 , 15443034 , 15443039 , 15443040 , 15443062 , 15443067 , 15443069 , 15443103 , 15443119 , 15443123 , 15443126 , 15443130 , 15443142 , 15443148 , 15443154 , 15443156 , 15443228 , 15443248 , 15443317 , 15443342 , 15443346 , 15443365 , 15443401 , 15443403 , 15443426 , 15443427 , 15443441 , 15443445 , 15443474 , 15443475 , 15443478 , 15443529 , 15443533 , 15443535 , 15443537 , 15443542 , 15443543 , 15443589 , 15443607 , 15443609 , 15443611 , 15443614 , 15443618 , 15443619 , 15443626 , 15443629 , 15443635 , 15443636 , 15443637 , 15443640 , 15443641 , 15443642 , 15443650 , 15443653 , 15443655 , 15443668 , 15443671 , 15443683 , 15443688 , 15443719 , 15443744 , 15443756 , 15443757 , 15443759 , 15443760 , 15443762 , 15443765 , 15443771 , 15443781 , 15443785 , 15443787 , 15443789 , 15443799 , 15443801 , 15443808 , 15443820 , 15443824 , 15443825 , 15443830 , 15443833 , 15443837 , 15443853 , 15443859 , 15443863 , 15443865 , 15443868 , 15443879 , 15443880 , 15443895 , 15443910 , 15443919 , 15443923 , 15443927 , 15443928 , 15443929 , 15443934 , 15443935 , 15443936 , 15443942 , 15443943 , 15443944 , 15443946 , 15443947 , 15443949 , 15443950 , 15443951 , 15443959 , 15443961 , 15443962 , 15443963 , 15443965 , 15443970 , 15443976 , 15443977 , 15443978 , 15443986 , 15443987 , 15443988 , 15443992 , 15443993 , 15443996 , 15443999 , 15444000 , 15444002 , 15444003 , 15444004 , 15444005 , 15444008 , 15444012 , 15444030 , 15444037 , 15444040 , 15444041 , 15444055 , 15444060 , 15444065 , 15444067 , 15444069 , 15444072 , 15444084 , 15444100 , 15444107 , 15444109 , 15444111 , 15444115 , 15444116 , 15444118 , 15444119 , 15444120 , 15444122 , 15444123 , 15444124 , 15444125 , 15444127 , 15444128 , 15444129 , 15444132 , 15444133 , 15444134 , 15444135 , 15444136 , 15444137 , 15444139 , 15444140 , 15444141 , 15444142 , 15444143 , 15444144 , 15444145 , 15444147 , 15444150 , 15444151 , 15444152 , 15444153 , 15444154 , 15444156 , 15444157 , 15444161 , 15444164 , 15444166 , 15444167 , 15444168 , 15444171 , 15444173 , 15444175 , 15444176 , 15444183 , 15444184 , 15444185 , 15444186 , 15444187 , 15444188 , 15444190 , 15444192 , 15444193 , 15444196 , 15444200 ,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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