FDAFDA · Food and drugs·Recall number Z-3139-2024
Alaris PCA Module Model 8120, 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: 8120 UDI-DI codes: 10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002 Serial Numbers: 16473112 16474187 16458453 16458381 16458632 16472825 16456729 16457626 16453240 16458585 16450364 16459191 16458699 16473046 16458427 16473677 16472463 16459701 16472829 16458736 16458700 16457828 16460132 16455368 16472831 16473116 16457873 16460396 16473618 16473688 16458544 16458121 16473391 16527718 16527910 16441259 16441394 16528387 16441214 16477919 16441048 16525578 16440759 16441453 16525916 16441034 16441160 16441164 16450345 16441601 16454386 16442620 16479558 16452454 16358256 16452960 16453953 16452089 16472866 16452442 16449483 16282569 16452076 16473123 16453256 16448217 16452996 16438128 16453852 16282541 16453263 16453423 16454448 16452576 16450489 16453424 16453702 16453853 16452088 16452445 16453527 16298268 16454345 16282360 16452394 16280503 16452485 16298349 16440752 16441277 16453848 16451983 16453700 16454300 16453421 16438875 16452129 16453535 16452508 16472830 16472480 16442014 16282559 16441295 16450415 16450090 16452417 16471744 16452387 16453522 16453579 16452626 16452536 16282579 16441545 16472995 16282616 16438173 16449362 16449280 16449336 16527580 16441101 16525189 16526900 16526177 16511913 16441474 16515632 16441290 16527326 16440746 16440745 16283136 16284350 16284295 16278278 16282406 16282701 16284376 16284539 16285656 16283024 16285385 16280047 16282941 16282871 16284654 16285713 16280325 16284548 16282671 16284131 16282990 16282603 16285595 16280391 16285788 16285305 16284591 16285009 16280279 16283279 16284313 16285063 16282546 16283207 16282639 16282557 16283012 16284466 16279819 16283281 16282407 16282805 16282548 16284794 16285661 16283272 16282566 16285657 16284238 16285665 16285617 16279174 16283177 16283230 16285241 16282586 16280036 16280501 16284709 16284608 16285706 16285658 16285662 16282640 16282259 16282680 16284959 16284777 16285378 16285693 16279615 16284070 16282678 16279855 16278366 16285509 16282857 16282700 16283876 16279578 16282608 16285592 16285664 16282596 16284183 16282583 16359215 16359421 16399909 16359158 16359537 16397508 16358882 16359302 16281960 16399657 16282573 16359456 16280308 16358349 16359495 16282611 16282367 16282580 16360101 16359586 16360086 16285672 16282543 16282001 16359475 16282605 16359857 16282571 16358861 16359086 16282595 16359390 16359524 16283204 16282197 16359695 16359703 16359858 16358822 16285395 16358710 16285702 16283055 16285366 16360119 16282235 16359217 16279603 16314048 16301945 16279654 16282362 16282842 16282663 16279860 16278456 16282590 16283210 16284330 16284770 16285653 16282636 16284375 16283228 16282621 16282648 16284005 16285659 16282553 16282830 16285675 16284334 16282874 16283892 16279617 16285227 16279562 16280023 16279550 16280182 16282646 16278386 16284135 16282593 16279990 16285593 16280141 16282563 16285363 16280307 16282770 16279992 16280298 16284382 16282612 16282937 16282552 16282674 16280235 16282361 16282649 16280435 16282683 16285650 16284115 16285505 16284237 16282404 16282572 16283068 16280496 16282578 16280175 16282561 16284296 16280253 16281983 16282973 16285498 16285618 16282664 16279988 16282619 16399569 16359432 16359446 16359836 16359584 16358849 16282554 16280762 16359793 16359310 16285590 16358921 16282581 16359106 16359511 16282576 16358703 16359304 16284936 16358693 16359612 16358301 16283277 16282589 16282670 16359092 16359216 16279606 16282642 16285701 16359108 16283900 16280559 16358919 16283098 16358975 16397963 16359332 16398741 16284393 16283001 16359481 16284180 16282200 16282604 16280505 16282026 16282196 16282531 16359219 16544301 16543199 16543502 16540811 16544307 16544273 16536911 16539663 16544195 16540987 16539173 16540578 16540229 16537675 16539699 16543268 16540652 16536923 16542593 16540383 16537836 16544131 16542622 16543170 16540954 16539018 16540552 16544042 16540045 16544718 16540942 16540381 16539976 16540988 16543496 16536496 1654
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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