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FDAFDA · Food and drugs·Recall number Z-0207-2014

Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

Published November 20, 2013 · Recall initiated: February 5, 2012

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

Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not

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, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
Lot
List No. 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 , 138403
Risk classification
Class II
Area (FDA)
device
Country
United States

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