FDAFDA · Food and drugs·Recall number Z-0287-2014
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 12391; Serial Numbers: 13840001 , 13840002 , 13840003 , 13840004 , 13840005 , 13840006 , 13840007 , 13840008 , 13840009 , 13840010 , 13840011 , 13840012 , 13840013 , 13840014 , 13840015 , 13840016 , 13840017 , 13840018 , 13840019 , 13840020 , 13840021 , 13840022 , 13840023 , 13840024 , 13840025 , 13840026 , 13840027 , 13840028 , 13840029 , 13840030 , 13840031 , 13840032 , 13840033 , 13840034 , 13840035 , 13840036 , 13840037 , 13840038 , 13840039 , 13840040 , 13840041 , 13840042 , 13840043 , 13840044 , 13840045 , 13840046 , 13840047 , 13840048 , 13840049 , 13840050 , 13840051 , 13840052 , 13840053 , 13840054 , 13840055 , 13840056 , 13840057 , 13840058 , 13840059 , 13840060 , 13840061 , 13840062 , 13840063 , 13840064 , 13840065 , 13840066 , 13840067 , 13840068 , 13840069 , 13840070 , 13840071 , 13840072 , 13840073 , 13840074 , 13840075 , 13840076 , 13840077 , 13840078 , 13840079 , 13840080 , 13840081 , 13840082 , 13840083 , 13840084 , 13840085 , 13840086 , 13840087 , 13840088 , 13840089 , 13840090 , 13840091 , 13840092 , 13840093 , 13840094 , 13840095 , 13840096 , 13840097 , 13840098 , 13840099 , 13840100 , 13840101 , 13840102 , 13840103 , 13840104 , 13840105 , 13840106 , 13840107 , 13840108 , 13840109 , 13840110 , 13840111 , 13840112 , 13840113 , 13840114 , 13840115 , 13840116 , 13840117 , 13840118 , 13840119 , 13840120 , 13840122 , 13840123 , 13840124 , 13840125 , 13840126 , 13840127 , 13840128 , 13840129 , 13840130 , 13840131 , 13840132 , 13840133 , 13840134 , 13840135 , 13840136 , 13840137 , 13840138 , 13840139 , 13840140 , 13840141 , 13840142 , 13840143 , 13840144 , 13840145 , 13840146 , 13840147 , 13840148 , 13840149 , 13840150 , 13840151 , 13840152 , 13840153 , 13840154 , 13840155 , 13840156 , 13840157 , 13840158 , 13840159 , 13840160 , 13840161 , 13840162 , 13840163 , 13840164 , 13840165 , 13840166 , 13840167 , 13840168 , 13840169 , 13840170 , 13840171 , 13840172 , 13840173 , 13840174 , 13840175 , 13840176 , 13840177 , 13840178 , 13840179 , 13840180 , 13840181 , 13840182 , 13840183 , 13840184 , 13840185 , 13840187 , 13840188 , 13840189 , 13840190 , 13840191 , 13840192 , 13840193 , 13840194 , 13840195 , 13840196 , 13840197 , 13840198 , 13840199 , 13840200 , 13840201 , 13840202 , 13840203 , 13840204 , 13840205 , 13840206 , 13840207 , 13840208 , 13840209 , 13840210 , 13840211 , 13840212 , 13840213 , 13840214 , 13840215 , 13840216 , 13840217 , 13840218 , 13840219 , 13840220 , 13840221 , 13840222 , 13840223 , 13840224 , 13840225 , 13840226 , 13840227 , 13840228 , 13840229 , 13840230 , 13840231 , 13840232 , 13840233 , 13840234 , 13840235 , 13840236 , 13840237 , 13840238 , 13840239 , 13840240 , 13840241 , 13840242 , 13840243 , 13840244 , 13840245 , 13840246 , 13840247 , 13840248 , 13840249 , 13840250 , 13840251 , 13840252 , 13840253 , 13840254 , 13840255 , 13840256 , 13840257 , 13840258 , 13840259 , 13840260 , 13840261 , 13840262 , 13840263 , 13840264 , 13840265 , 13840266 , 13840267 , 13840268 , 13840269 , 13840270 , 13840271 , 13840272 , 13840273 , 13840274 , 13840275 , 13840276 , 13840277 , 13840278 , 13840279 , 13840280 , 13840281 , 13840282 , 13840283 , 13840284 , 13840285 , 13840286 , 13840287 , 13840288 , 13840289 , 13840290 , 13840291 , 13840292 , 13840293 , 13840294 , 13840295 , 13840296 , 13840297 , 13840298 , 13840299 , 13840301 , 13840302 , 13840303 , 13840304 , 13840305 , 13840306 , 13840307 , 13840308 , 13840309 , 13840310 , 13840311 , 13840312 , 13840313 , 13840314 , 13840315 , 13840316 , 13840317 , 13840318 , 13840319 , 13840320 , 13840321 , 13840322 , 13840323 , 13840324 , 13840325 , 13840326 , 13840327 , 13840328 , 13840329 , 13840330 , 13840331 , 13840332 , 13840333 , 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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