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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0209-2014

*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; 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

Publicado el 20 de noviembre de 2013 · Inicio del retiro: 5 de febrero de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hospira Inc.
Distribuidor
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.
Lote
List No. 12618; Serial Numbers: 14040001 , 14040002 , 14040003 , 14040004 , 14040005 , 14040006 , 14040008 , 14040009 , 14040010 , 14040011 , 14040012 , 14040014 , 14040015 , 14040016 , 14040017 , 14040018 , 14040019 , 14040020 , 14040021 , 14040022 , 14040023 , 14040024 , 14040025 , 14040026 , 14040027 , 14040027 , 14040027 , 14040028 , 14040028 , 14040028 , 14040029 , 14040030 , 14040031 , 14040033 , 14040034 , 14040034 , 14040034 , 14040035 , 14040036 , 14040037 , 14040038 , 14040039 , 14040040 , 14040041 , 14040042 , 14040043 , 14040044 , 14040045 , 14040047 , 14040048 , 14040049 , 14040050 , 14040051 , 14040052 , 14040053 , 14040054 , 14040056 , 14040059 , 14040061 , 14040062 , 14040063 , 14040064 , 14040065 , 14040066 , 14040067 , 14040068 , 14040069 , 14040070 , 14040071 , 14040072 , 14040073 , 14040074 , 14040075 , 14040076 , 14040077 , 14040078 , 14040079 , 14040080 , 14040081 , 14040082 , 14040083 , 14040084 , 14040085 , 14040086 , 14040087 , 14040088 , 14040089 , 14040090 , 14040091 , 14040092 , 14040093 , 14040094 , 14040095 , 14040096 , 14040097 , 14040098 , 14040099 , 14040100 , 14040101 , 14040103 , 14040104 , 14040105 , 14040106 , 14040107 , 14040108 , 14040109 , 14040110 , 14040111 , 14040112 , 14040113 , 14040115 , 14040116 , 14040117 , 14040118 , 14040119 , 14040120 , 14040121 , 14040122 , 14040123 , 14040124 , 14040125 , 14040128 , 14040129 , 14040130 , 14040131 , 14040132 , 14040133 , 14040134 , 14040135 , 14040136 , 14040138 , 14040139 , 14040140 , 14040141 , 14040142 , 14040143 , 14040144 , 14040145 , 14040146 , 14040148 , 14040149 , 14040150 , 14040152 , 14040153 , 14040154 , 14040155 , 14040156 , 14040156 , 14040156 , 14040157 , 14040158 , 14040159 , 14040160 , 14040161 , 14040162 , 14040163 , 14040164 , 14040165 , 14040166 , 14040167 , 14040168 , 14040169 , 14040170 , 14040171 , 14040172 , 14040173 , 14040174 , 14040175 , 14040176 , 14040178 , 14040179 , 14040180 , 14040181 , 14040181 , 14040181 , 14040182 , 14040183 , 14040184 , 14040185 , 14040186 , 14040187 , 14040189 , 14040190 , 14040191 , 14040192 , 14040193 , 14040194 , 14040196 , 14040198 , 14040199 , 14040200 , 14040201 , 14040202 , 14040203 , 14040205 , 14040206 , 14040207 , 14040208 , 14040209 , 14040210 , 14040211 , 14040212 , 14040213 , 14040214 , 14040215 , 14040216 , 14040217 , 14040219 , 14040220 , 14040221 , 14040223 , 14040224 , 14040225 , 14040226 , 14040227 , 14040228 , 14040229 , 14040230 , 14040231 , 14040232 , 14040233 , 14040234 , 14040235 , 14040236 , 14040238 , 14040239 , 14040240 , 14040242 , 14040243 , 14040244 , 14040245 , 14040246 , 14040247 , 14040248 , 14040249 , 14040250 , 14040251 , 14040252 , 14040253 , 14040254 , 14040255 , 14040256 , 14040257 , 14040258 , 14040260 , 14040261 , 14040262 , 14040263 , 14040264 , 14040265 , 14040266 , 14040267 , 14040269 , 14040270 , 14040271 , 14040272 , 14040274 , 14040275 , 14040276 , 14040277 , 14040278 , 14040279 , 14040280 , 14040282 , 14040283 , 14040284 , 14040285 , 14040286 , 14040287 , 14040288 , 14040289 , 14040290 , 14040291 , 14040292 , 14040293 , 14040294 , 14040295 , 14040296 , 14040297 , 14040298 , 14040299 , 14040300 , 14040301 , 14040302 , 14040303 , 14040304 , 14040305 , 14040306 , 14040307 , 14040308 , 14040309 , 14040310 , 14040310 , 14040310 , 14040311 , 14040312 , 14040313 , 14040314 , 14040315 , 14040316 , 14040317 , 14040318 , 14040319 , 14040320 , 14040321 , 14040323 , 14040324 , 14040326 , 14040327 , 14040328 , 14040329 , 14040330 , 14040331 , 14040332 , 14040333 , 14040334 , 14040335 , 14040336 , 14040337 , 14040338 , 14040339 , 14040340 , 14040341 , 14040342 , 14040343 , 14040344 , 14040345 , 14040347 , 14040348 , 14040349 , 140403
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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