FDAFDA · Food and drugs·Recall number Z-3138-2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Published September 25, 2024 · Recall initiated: August 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, 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, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
- Lot
- Model Number: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859 16355147 16385733 16356177 16358090 16405681 16405365 16391644 16365407 16380736 16406383 16370288 16342333 16406520 16340432 16406486 16342209 16339360 16356089 16379852 16406293 16365679 16343510 16340086 16394051 16372192 16406547 16392519 16342393 16370109 16378495 16380421 16406296 16366356 16406474 16376814 16333959 16390881 16355769 16405567 16405941 16380737 16406213 16391082 16405988 16340999 16334088 16370963 16405969 16406245 16406332 16406224 16386484 16406461 16394270 16406295 16381987 16405986 16337357 16405861 16373958 16388828 16406482 16377465 16406473 16378711 16343560 16388488 16384288 16342306 16342387 16355791 16366771 16406518 16398407 16392150 16339100 16339855 16385755 16386553 16360664 16394173 16406317 16388663 16389674 16406471 16390470 16402464 16341647 16365652 16405580 16343049 16390351 16365011 16406536 16406484 16357255 16344098 16405945 16405623 16340058 16381253 16398304 16406479 16405601 16392485 16406540 16374550 16339803 16406524 16377605 16372148 16406514 16406539 16340891 16406457 16339474 16370175 16340358 16406543 16369665 16366663 16341788 16380626 16406511 16406502 16406519 16400608 16405768 16406552 16406517 16405448 16203194 16202076 16202216 16202221 16203212 16202062 16203196 16202042 16203116 16203187 16202205 16203083 16203208 16203198 16202983 16203185 16203120 16202120 16203152 16203200 16203146 16203125 16203149 16203081 16192323 16192072 16192120 16192208 16376983 16358358 16358871 16431754 16344417 16432467 16431907 16507863 16433198 16432477 16433311 16506147 16345129 16433053 16433227 16490382 16431647 16508003 16508095 16506196 16432231 16344327 16431706 16346301 16344250 16506376 16505293 16431887 16504733 16502286 16343587 16467604 16506192 16508094 16508165 16343705 16432864 16431780 16506383 16430773 16507510 16506184 16431981 16507776 16508092 16505498 16433287 16507773 16516243 16513732 16345378 16513505 16345451 16514864 16470079 16517398 16508555 16487515 16514047 16512687 16454266 16494772 16333872 16505205 16514046 16476213 16517156 16514059 16517001 16513248 16343385 16516536 16344549 16513686 16344251 16454613 16454566 16463391 16466677 16450162 16454523 16434291 16452410 16513958 16454578 16454267 16484075 16435789 16509151 16516162 16346158 16485006 16515343 16516161 16512665 16454555 16345571 16513243 16346292 16454577 16468320 16513978 16514496 16454517 16287697 16287349 16502278 16308136 16308098 16309720 16309530 16309620 16308589 16308358 16308430 16308610 16309934 16308537 16309977 16308120 16319782 16309965 16308509 16308159 16308542 16308520 16309974 16307871 16310048 16308348 16308635 16308494 16308405 16309745 16309969 16308248 16308221 16319675 16309908 16309608 16287568 16287202 16287525 16287624 16287346 16454488 16310062 16309652 16309711 16505081 16517132 16431961 16308620 16441976 16309972 16454624 16345952 16512682 16488810 16440889 16308407 16345412 16346589 16513946 16518830 16484372 16514862 16516225 16453619 16505870 16513421 16513721 16308823 16346506 16514026 16516836 16308365 16452427 16308216 16454255 16309726 16500240 16513109 16308394 16460359 16345054 16287573 16309629 16516135 16483720 16515380 16465465 16454452 16454541 16452456 16470843 16454560 16454363 16513718 16454352 16433047 16435956 16345102 16432418 16308580 16513684 16310014 16454002 16309487 16308265 16309732 16430985 16308889 16309668 16308759 16515725 16454302 16343971 16308118 16309979 16519113 16309941 16513312 16516842 16309416 16396400 16432469 16513959 16345921 16508988 16309121 16365912 16345615 16308544 16344824 16487350 16287942 16502129 16365219 16411253 16437478 16438214 16437014 16411219 16438313 16410722 16438094 16438329 16439078 16411101 16409751 16410351 16364505 16411074 16439164 16440212 16408832 16363750 16438015 164112
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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