Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.

Recall details

Manufacturer

Baxter Healthcare Corporation

Distributor

Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa

Lot

Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700010, 700012, 700013, 700014, 700017, 700018, 700020, 700021, 700022, 700023, 700024, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700037, 700038, 700039, 700040, 700041, 700042, 700043, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700053, 700054, 700055, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700069, 700071, 700073, 700075, 700076, 700077, 700080, 700081, 700082, 700085, 700086, 700088, 700089, 700090, 700093, 700094, 700095, 700097, 700098, 700100, 700101, 700103, 700104, 700106, 700108, 700109, 700110, 700111, 700112, 700114, 700117, 700118, 700119, 700120, 700121, 700123, 700126, 700127, 700129, 700130, 700132, 700133, 700134, 700135, 700137, 700138, 700139, 700141, 700142, 700143, 700144, 700145, 700147, 700149, 700151, 700152, 700153, 700156, 700157, 700158, 700159, 700161, 700162, 700163, 700165, 700166, 700168, 700169, 700170, 700172, 700173, 700174, 700175, 700176, 700177, 700178, 700179, 700180, 700183, 700184, 700187, 700189, 700193, 700194, 700195, 700197, 700201, 700202, 700203, 700204, 700205, 700206, 700207, 700208, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700217, 700218, 700219, 700220, 700222, 700223, 700224, 700225, 700226, 700229, 700231, 700232, 700233, 700234, 700235, 700236, 700237, 700238, 700239, 700240, 700241, 700242, 700243, 700244, 700245, 700246, 700248, 700249, 700250, 700251, 700252, 700253, 700255, 700256, 700257, 700258, 700259, 700260, 700263, 700265, 700267, 700268, 700269, 700271, 700272, 700273, 700274, 700275, 700277, 700278, 700280, 700282, 700283, 700284, 700285, 700286, 700287, 700288, 700289, 700292, 700293, 700294, 700295, 700297, 700298, 700299, 700301, 700302, 700303, 700305, 700306, 700307, 700308, 700309, 700310, 700311, 700312, 700314, 700316, 700317, 700318, 700319, 700320, 700321, 700322, 700323, 700324, 700326, 700327, 700328, 700329, 700330, 700331, 700332, 700333, 700334, 700335, 700338, 700339, 700340, 700341, 700343, 700344, 700345, 700346, 700348, 700349, 700350, 700351, 700352, 700353, 700354, 700355, 700357, 700358, 700359, 700360, 700361, 700362, 700363, 700364, 700365, 700366, 700367, 700368, 700369, 700370, 700371, 700372, 700373, 700374, 700375, 700376, 700377, 700378, 700379, 700380, 700381, 700382, 700383, 700384, 700385, 700386, 700387, 700388, 700389, 700390, 700392, 700395, 700396, 700398, 700399, 700400, 700401, 700402, 700403, 700404, 700405, 700406, 700407, 700408, 700409, 700410, 700411, 700412, 700413, 700414, 700415, 700416, 700417, 700419, 700420, 700421, 700422, 700423, 700424, 700425, 700426, 700427, 700428, 700429, 700433, 700434, 700436, 700437, 700438, 700439, 700440, 700441, 700442, 700443, 700444, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700456, 700457, 700458, 700459, 700460, 700461, 700462, 700463, 700464, 700466, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700478, 700479, 700480, 700481, 700483, 700484, 700485, 700489, 700490, 700491, 700494, 700495, 700496, 700497, 700502, 700503, 700504, 700505, 700506, 700507, 700508, 700509, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700517, 700519, 700520, 700524, 700525, 700526, 700527, 700528, 700530, 700531, 700532, 700533, 700534, 700536, 700537, 700538, 700539, 700540, 700542, 700548, 700552, 700553, 700555, 700556, 700557, 700558, 700560, 700561, 700562, 700563, 700564, 700565, 700566, 700567, 700568, 700569, 700570, 700571, 700572, 700573, 700574, 700575, 700576, 700577, 700578, 700579, 700580, 700581, 700582, 700583, 700584, 700585, 700586, 700587, 700588, 700589, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700598, 700599, 700600, 700601, 700602, 700603, 700604, 700605, 700606, 700607, 700608, 700611, 700612, 700613, 700614, 700616, 700617, 700618, 700619, 700620, 700621, 700622, 70062

Risk classification

Class I

Area (FDA)

device

Country

United States