FDAFDA · Alimentos y medicamentos·N.º oficial Z-1567-2014
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Publicado el 21 de mayo de 2014 · Inicio del retiro: 23 de abril de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- CareFusion 303, Inc.
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.
- Lote
- Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963 14036178 14036191 14036215 14036219 14036422 12773501 13184780 13932274 13932283 13932301 13932329 13932333 13990520 13990521 13990661 13990694 13990697 13990698 13990699 13990701 13990738 13990741 13990742 13990807 13990872 13990928 13990930 13990938 13990955 13990957 13990958 13990976 13990978 13990982 13990985 13990999 13991000 13991002 13991008 13991013 13991014 13991020 13991028 13991031 13991037 13991044 13991048 13991052 13991056 13991066 13991073 13991084 13991088 13991089 13991090 13991107 13991109 13991150 13991167 13991168 13991169 13991170 13991171 13991184 13991196 13991225 13991229 13991231 13991247 13991248 13991306 13991308 13991312 13991339 13991342 13991375 13991379 13991458 13991495 13991502 13991525 13991527 13991564 13991566 13991577 13991589 13991591 13991592 13991600 13991607 13991609 13991613 13991615 13991616 13991724 13991725 13991738 13991741 13991749 13991750 13991751 13991752 13991769 13991771 13991772 13991774 13991776 13991778 13991785 13991787 13991809 13991827 13991828 13991829 13991831 13991845 13991849 13991850 13991856 13991858 13991859 13991860 13991865 13991866 13991871 13991876 13991877 13991880 13991882 13991889 13991890 13991904 13991912 13991925 13991926 13991928 13991929 13991930 13991931 13991932 13991933 13991934 13991938 13991939 13991954 13991956 13991958 13991960 13991969 13991971 13991972 13991984 13991990 13991992 13991993 13991999 13992001 13992003 13992004 13992006 13992007 13992015 13992029 13992030 13992069 13992070 13992071 13992075 13992076 13992080 13992090 13992095 13992104 13992109 13992129 13992157 13992158 13992164 13992170 13992179 13992199 13992203 13992212 13992217 13992226 13992228 13992238 13992239 13992241 13992242 13992251 13992257 13992258 13992259 13992270 13992274 13992275 13992322 13992324 13992358 13992367 13992372 13992374 13992377 13992382 13992383 13992409 13992418 13992424 13992426 13992427 13992434 13992436 13992446 13992452 13992456 13992457 13992459 13992461 13992466 13992469 13992496 13992512 13992513 13992515 13992516 13992524 13992526 13992527 13992528 13992537 13992540 13992543 13992545 13992547 13992548 13992550 13992555 13992593 13992615 13992617 13992620 13992624 13992627 13992629 13992631 13992632 13992633 13992634 13992643 13992644 13992647 13992649 13992652 13992658 13992659 13992662 13992664 13992678 13992680 13992681 13992682 13992683 13992684 13992688 13992694 13992700 13992701 13992702 13992708 13992712 13992713 13992714 13992715 13992716 13992717 13992727 13992730 13992732 13992733 13992741 13992744 13992747 13992766 13992769 13992770 13992775 13992778 13992792 13992795 13992808 13992813 13992814 13992821 13992836 13992837 13992839 13992847 13992859 13992860 13992866 13992867 13992903 13992942 13992991 13992998 13993015 13993016 13993021 13993077 13993092 13993103 13993105 13993192 13993368 13993400 13993403 13994400 13994902 13994903 13994914 13994916 13994918 13994938 13994940 13994957 13994972 13994975 13994976 13994977 13994982 13994983 13994988 13994992 13994994 13994995 13994998 13995001 13995031 13995032 13995033 13995035 13995047 13995116 13995117 13995118 13995121 13995124 13995125 13995126 13995127 13995128 13995130 13995131 13995135 13995137 13995142 13995146 13995147 13995154 13995158 13995159 13995160 13995164 13995199 13995201 13995207 13995208 13995209 13995216 13995217 13995226 13995227 13995228
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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