FDAFDA · Food and drugs·Recall number Z-0026-2018
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. 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 the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
Published October 25, 2017 · Recall initiated: August 9, 2017
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
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
- Lot
- All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011 and November 2011; Serial Numbers - Serial 13537720 13537735 13538005 13538811 13540340 13541935 13543108 13543503 13543666 13544201 13544350 13545092 13545892 13546315 13546638 13548091 13550608 13550614 13550629 13550670 13552666 13552667 13552781 13552782 13553628 13553661 13553714 13553730 13553739 13554035 12851369 12851850 9879510 9879561 9880323 9880838 9881158 12564799 13157405 13563286 13566911 13566932 13566933 13567118 13585121 13585213 13585493 13586248 13586314 13586329 13586339 13586340 13586408 13586578 13586723 13586731 13586733 13586738 13586746 13586758 13586763 13586764 13586768 13586775 13586782 13586784 13586793 13586795 13586797 13586798 13586819 13586820 13586835 13586836 13586839 13586855 13586860 13586877 13586878 13586898 13586952 13586957 13586960 13586967 13586976 13587076 13587077 13587118 13587220 13587231 13587232 13587233 13587262 13587263 13587266 13587289 13587290 13587291 13587297 13587312 13587315 13587345 13587398 13196293 13203541 13207333 13213463 13214795 13217554 13219137 13219971 13375015 13375617 13375737 12471635 9857470 9858862 9858865 9859690 9860106 9860746 13184877 13186091 13582527 13582709 13599442 12460530 12474814 12771113 13619912 13620162 13585671 13566067 13616956 13545222 13545224 13545250 13545260 13545262 13550278 13550317 13550318 13550319 13550325 13550337 13550365 13550369 13550370 13550379 13553239 13549816 13549832 13549886 13549901 13549903 13550267 13550271 13550339 13550340 13550345 13550346 13550355 13550356 13550357 13550366 13553126 13553134 13553403 13553415 13568914 13568950 13569155 13569179 13569248 13569694 13569829 13569830 13569838 13569839 13569854 13569876 13569947 13569948 13569953 13569955 13569957 13570013 13570014 13570015 13570017 13570022 13570023 13570052 13570063 13570076 13570077 13570127 13570128 13570137 13570138 13570168 13570184 13570198 13570222 13570236 13570249 13570255 13570256 13570263 12518795 12520618 12520990 13139496 13152562 13153423 13550976 13605208 13605881 13605956 13620375 13620540 13620587 13620902 13620923 13552790 13556036 13556048 13556052 13556056 13558162 13558197 13558234 13142008 13142059 13142277 13142311 13550252 13552900 13552901 13554258 13554809 13554826 13554865 13554878 13554887 13555000 13555023 13036704 4130472 13551713 13551714 13551715 13551750 13552281 13122441 13606144 13606620 13606680 13606687 12652922 13551874 13554663 13555012 13555162 13555172 13555189 13555277 13555711 13555714 13555740 13555743 13562785 13562126 13562559 13566817 13566828 13566873 13618695 13618974 13620108 13620109 13623007 13626334 4049223 12389924 12390048 12390059 12390063 12390110 12421349 13410265 13481070 13415581 13415684 13546628 13546711 13550790 13550951 9895104 12548328 12366930 12367649 12367659 12367775 12367815 12368485 13550687 13550967 13537121 13537307 13537615 13537708 13537929 13538004 13538163 13538907 13539151 13539520 13539841 13539844 13540113 13540190 13540375 13540560 13540586 13541136 13541300 13541571 13541863 13541874 13542038 13542061 13542222 13542379 13542436 13542446 13542474 13542525 13542684 13542888 13542903 13542957 13542989 13543284 13543448 13543508 13543610 13543667 13543668 13543746 13543917 13544255 13544355 13545718 13546268 13546294 13546518 13546684 13546696 13546821 13547115 13547166 13547222 13547288 13547340 13547345 13547378 13547382 13547407 13547413 13547427 13547530 13547563 13548096 13548131 13548135 13548173 13548309 13548311 13548425 13548455 13549072 13549099 13549100 13549225 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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