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: 192964 Lot/code info: Model Number: 8100 UDI-DI code: 10885403810046, 10885403810039, 10885403810015 Serial Numbers: 16448779 16451711 16451209 16450973 16450971 16451760 16407678 16411676 16388896 16405467 16408857 16387206 16405786 16407463 16410819 16407769 16399159 16410420 16411470 16409931 16409006 16411571 16409107 16388799 16472492 16409660 16410466 16404846 16409933 16410968 16406453 16406013 16408309 16402653 16410415 16411500 16411069 16407539 16410537 16451801 16450922 16451705 16448898 16451601 16448918 16450847 16453708 16451857 16451608 16451642 16372116 16451808 16451067 16451690 16451895 16445957 16453760 16451083 16453750 16448376 16450498 16451078 16448899 16451051 16453718 16450801 16449025 16450557 16453778 16448576 16450674 16451410 16448921 16451745 16451356 16451907 16453721 16451788 16450769 16451819 16448338 16449113 16451236 16450609 16450928 16448781 16451823 16450969 16451794 16451840 16451856 16445998 16451321 16451787 16444660 16407683 16410698 16410619 16403032 16472342 16408257 16384862 16407887 16408415 16409022 16406455 16409686 16411724 16410412 16565972 16387963 16409990 16411378 16407898 16409960 16403700 16407660 16389103 16472045 16405794 16409501 16410040 16409063 16410492 16407922 16405757 16410823 16410875 16410360 16410960 16403230 16411134 16409981 16408763 16330176 16389104 16410530 16408195 16407470 16407516 16451525 16453706 16453685 16450810 16448629 16454181 16451518 16451924 16451683 16450580 16451470 16374696 16450837 16450974 16445414 16451618 1
10885403810046, 10885403810039, 10885403810015
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.