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: 20145 Lot/code info: Model Number: 8110 UDI-DI codes: 10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267 Serial Numbers: 16557517 16557523 16558377 16558030 16557553 16552258 16558259 16555767 16557678 16557941 16557706 16557760 16201478 16204104 16201486 16207089 16204181 16201491 16201552 16206906 16203916 16201484 16201546 16203885 16201616 16207145 16201496 16201611 16206327 16204189 16203959 16206827 16204092 16206937 16206843 16201523 16201556 16206381 16206138 16204129 16205794 16204207 16201166 16201493 16204172 16201517 16201564 16204027 16206473 16207211 16204173 16203733 16206915 16206904 16201480 16201489 16201498 16201623 16201481 16201163 16206319 16201540 16201528 16201156 16201479 16206787 16206311 16206911 16206331 16307400 16294280 16374263 16307376 16373254 16307505 16306734 16306695 16306293 16305549 16306102 16306495 16306346 16305864 16307132 16305897 16307421 16306782 16412939 16306691 16304540 16305993 16306144 16306724 16307095 16307238 16307031 16306324 16306731 16307165 16307138 16305383 16307094 16307005 16306282 16307215 16306544 16307163 16306844 16306988 16305863 16306783 16306258 16307479 16304883 16306852 16307378 16307136 16306866 16307049 16306903 16305010 16306952 16307091 16304922 16307389 16294173 16306250 16307508 16306530 16305266 16305361 16306912 16307024 16305985 16307310 16306915 16305918 16408571 16424860 16428232 16395865 16419208 16422463 16396350 16405652 16411508 16405759 16410726 16431523 16382647 164105
10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267
Official record: FDA (Device enforcement) ↗
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