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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 61247
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-14
Initial Firm Notification of
Consignee or Public
Visit
Distribution Pattern Worldwide Distribution -- USA, including the state of CA, and country of Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Smiths Medical, MedfusionĀ® Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. 2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 2000258 2000259 2000260 2000261 2000262 2000263 2000264 2000265 2000266 2000267 2000268 2000269 2000270 2000271 2000272 2000273 2000274 2000275 2000276 2000277 2000278 2000279 2000280 2000281 2000282 2000283 2000284 2000285 2000286 2000287 2000288 2000289 2000290 2000291 2000292 2000293 2000294 2000295 2000296 2000297 2000298 2000299 2000300 2000301 2000302 2000303 2000304 2000305 2000307 2000308 2000309 2000310 2000311 2000312 2000313 2000314 2000315 2000316 2000317 2000318 2000319 2000320 2000321 2000322 2000323 2000324 2000325 2000326 2000327 2000328 2000329 2000330 2000331 2000332 2000333 2000334 2000336 2000337 2000338 2000339 2000340 2000341 2000342 2000343 2000344 2000345 2000346 2000347 2000348 2000349 2000350 2000351 2000352 2000353 2000354 2000355 2000356 2000357 2000358 2000359 2000360 2000361 2000362 2000363 2000364 2000365 2000366 2000367 2000368 2000369 2000370 2000371 2000372 2000373 2000374 2000375 2000376 2000377 2000378 2000379 2000380 2000381 2000382 2000383 2000384 2000385 2000386 2000387 2000388 2000389 2000390 2000391 2000392 2000393 2000394 2000395 2000396 2000397 2000398 2000399 2000400 2000401 2000402 2000403 2000404 2000405 2000406 2000408 2000409 2000412 2000413 2000414 2000415 2000416 2000417 2000418 2000419 2000422 2000423 2000425 2000426 2000428 2000430 2000431 2000433 2000434 2000436 2000437 2000438 2000439 2000440 2000441 2000442 2000443 2000445 2000446 2000447 2000448 2000449 2000450 2000451 2000452 2000453 2000454 2000455 2000456 2000457 2000458 2000459 2000460 2000461 2000462 2000463 2000464 2000465 2000466 2000467 2000468 2000469 2000470 2000471 2000472 2000473 2000474 2000475 2000476 2000477 2000478 2000479 2000480 2000481 2000482 2000483 2000484 2000485 2000486 2000487 2000488 2000489 2000490 2000491 2000492 2000493 2000494 2000495 2000496 2000497 2000498 2000499 2000500 2000501 2000502 2000503 2000504 2000505 2000506 2000507 2000508 2000509 2000510 2000511 2000512 2000513 2000514 2000515 2000516 2000517 2000518 2000519 2000520 2000521 2000522 2000523 2000524 2000525 2000526 2000527 2000528 2000529 2000530 2000531 2000532 2000533 2000534 2000535 2000536 2000537 2000538 2000539 2000540 2000541 2000542 2000543 2000544 2000545 2000546 2000547 2000548 2000549 2000550 2000551 2000552 2000553 2000554 2000555 2000556 2000557 2000558 2000559 2000560 2000561 2000562 2000563 2000564 2000565 2000566 2000567 2000568 2000569 2000570 2000571 2000572 2000573 2000574 2000575 2000576 2000577 2000578 2000579 2000580 2000581 2000582 2000583 2000584 2002080 2002081 2002082 2002083 2002084 2002085 2002086 2002087 2002089 2002090 2002091 2002092 2002093 2002094 2002095 2002096 2002097 2002098 2002099 2002100 2002101 2002102 2002103 2002104 2002105 2002106 2002107 2002108 2002109 2002110 2002111 2002112 2002113 2002114 2002115 2002116 2002117 2002118 2002119 2002120 2002121 2002122 2002123 2002124 2002125 2002128 2002129 2002130 2002131 2002132 2002133 2002134 2002135 2002136 2002137 2002138 2002139 2002140 2002141 2002142 2002143 2002144 2002145 2002146 2002147 2002148 2002149 2002150 2002151 2002152 2002153 2002154 2002155 2002156 2002157 2002158 2002159 2002160 2002161 2002162 2002163 2002164 2002165 2002166 2002167 2002168 2002169 2002170 2002171 2002173 2002174 2002175 2002176 2002177 2002178 2002179 2002180 2002181 2002182 2002183 2002184 2002185 2002186 2002187 2002188 2002189 2002190 2002204 2002205 2002206 2002207 2002208 2002209 2002210 2002211 2002212 2002213 2002214 2002215 2002217 2002218 2002219 2002220 2002221 2002222 2002223 2002224 2002225 2002226 2002227 2002228 2002229 2002230 2002231 2002232 2002233 2002234 2002235 2002236 2002237 2002238 2002239 2002240 2002242 2002244 2002245 2002246 2002247 2002248 2002249 2002250 2002251 2002252 2002254 2002256 2002257 2002258 2002259 2002260 2002261 2002262 2002263 2002264 2002265 2002267 2002268 2002269 2002270 2002271 2002273 2002274 2002275 2002276 2002277 2002278 2002279 2002280 2002281 2002282 2002284 2002285 2002286 2002287 2002288 2002289 2002290 2002291 2002292 2002293 2002294 2002295 2002296 2002297 2002298 2002299 2002300 2002301 2002302 2002303 2002304 2002306 2002308 2002309 2002310 2002311 2002312 2002313 2002314 2002315 2002316 2002317 2002318 2002319 2002320 2002321 2002322 2002323 2002325 2002326 2002327 2002328 2002329 2002330 2002331 2002332 2002333 2002334 2002335 2002336 2002337 2002338 2002340 2002341 2002342 2002343 2002345 2002346 2002348 2002349 2002350 2002351 2002352 2002353 2002354 2002357 2002358 2002359 2002360 2002371 2002372 2002373 2002374 2002375 2002376 2002377 2002563 2002564 2002565 2002566 2002567 2002568 2002569 2002570 2002571 2002572 2002573 2002574 2002575 2002576 2002577 2002578 2004514 2004528 2004531 2004536 2004537 2004538 2004541 2004542, and 2004550. Class I Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation. 607 pumps (257 USA, 350 Canada) Z-2107-2012
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