Company: Sigma International Medina
Date of Enforcement Report: 5/8/02
Class: II
PRODUCT
Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01.
Recall # Z-0991-2.
REASON
Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr.
CODE
The following serial numbers.
49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R, 49525R, 49527R, 49532R, 49536R, 50927R, 50931R, 50935R, 50973R, 51288R, 51496R, 51533R, 51658R, 51663R, 51666R, 51674R, 51679R, 51684R, 51690R, 51691R, 51692R, 51694R, 51700R, 51705R, 51751R, 51753R, 51754R, 51758R, 51761R, 51763R, 51766R, 51768R, 51769R, 51781R, 51783R, 51892R, 51893R, 51895R, 51896R, 51899R, 51901R, 51903R, 51910R, 51912R, 51913R, 51916R, 51917R, 51918R, 51919R, 51921R, 51922R, 51925R, 51926R, 51931R, 51932R, 51934R, 51935R, 51939R, 51940R, 51941R, 51944R, 51945R,
51949R, 51950R, 51951R, 51957R, 51958R, 51961R, 51962R, 51963R, 51966R, 51967R, 51969R, 51970R, 51974R, 51975R, 51979R, 51980R, 51981R, 51982R, 51983R, 51984R, 51985R, 51988R, 51989R, 51991R, 51993R, 51996R, 51999R, 52001R, 52003R, 52005R, 52007R, 52011R, 52018R, 52020R, 52021R, 52026R, 52030R, 52032R, 52033R, 52040R, 52041R, 52044R, 52049R, 52050R, 52054R, 52055R, 52057R, 52058R, 52062R, 52065R, 52067R, 52069R, 52072R, 52073R, 52075R, 52077R, 52078R, 52081R, 52084R, 52085R, 52089R, 52090R, 52091R, 52093R, 52094R, 52095R, 52098R, 52100R, 52106R, 52108R, 52117R, 52125R,
52127R, 52133R, 52263, 52343R, 52413R, 52620, 52744R, 52771R, 53016, 53047, 53052, 53131, 53146, 53154, 53626, 53813, 53862, 54147, 54458, 54471, 54476, 54570, 54574, 54639, 54643, 54757, 54910, 54929, 55063, 55110, 55115, 55202, 55232, 55267, 55274, 55332R, 55398R, 55414, 55433, 55658, 55738, 55757, 55764, 55786, 55815, 55832, 55835, 56205, 56323, 56442, 56479, 56506, 56511, 56540, 56578, 56722, 56785, 56838, 56872, 56924R, 56927R, 56928R, 56940R, 56968, 57199, 57365, 57800, 58070, 58399, 58447, 58686, 58707, 58745, 59541, 59669, 59774, 59758, 60120, 60296, 60342, 60343, 60344, 60347, 60348, 60350, 60354, 60357, 60366, 60367,
60368, 60421, 60422, 60427, 60429, 60431, 60433, 60435, 60437,
60439, 60442, 60559, 61024, 61395, 61469, 61626, 62026, 62035, 62041, 62042, 62045, 62053, 62054, 62056, 62057, 62058, 62195, 62252, 62259; and 62279 THRU 62418; and 62420, 62421, 62425, 62428, 62429, 62433, 62434, 62435, 62436, 62437, 62440, 62443, 62448, 62449, 62450, 62452, 62453, 62454, 62456, 62457, 62465, 62468, 62469, 62470, 62481, 62485, 62486, 62488, 62492, 62506, 62516, 62519, 62522, 62525, 62528, 62529, 62532, 62533, 62538, 62540, 62542, 62543, 62544, 62545, 62546.
RECALLING FIRM/MANUFACTURER
Sigma International Medina, NY, by letters between March 21 and 28, 2002.
Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
447 infusion pumps and 604 chips v. 3.50.01.
DISTRIBUTION
Nationwide and Canada.
