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.
Reason for recall: 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. Distribution: 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, Singapor Quantity: 10460 Lot/code info: 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 162845
10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.