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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61355

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 06, 2011
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1490-2012
Recall number
Z-1490-2012
Initiated
July 06, 2011
Classification
Class I
Status
Terminated
Quantity
63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

Code information

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704368, 704369, 704370, 704371, 704373, 704374, 704375, 704376, 704377, 704378, 704379, 704380, 704381, 704382, 704383, 704384, 704385, 704386, 704387, 704389, 704390, 704392, 704393, 704394, 704395, 704396, 704397, 704398, 704399, 704400, 704401, 704402, 704403, 704404, 704405, 704406, 704408, 704409, 704411, 704414, 704415, 704417, 704418, 704420, 704421, 704422, 704423, 704424, 704425, 704426, 704427, 704429, 704430, 704431, 704432, 704433, 704434, 704435, 704436, 704437, 704438, 704439, 704440, 704441, 704442, 704443, 704445, 704446, 704447, 704448, 704449, 704450, 704451, 704452, 704453, 704454, 704455, 704457, 704458, 704459, 704460, 704461, 704462, 704463, 704464, 704465, 704466, 704467, 704468, 704469, 704470, 704471, 704472, 704473, 704474, 704475, 704477, 704478, 704479, 704480, 704481, 704482, 704483, 704484, 704485, 704487, 704488, 704489, 704490, 704491, 704492, 704493, 704494, 704495, 704496, 704497, 704498, 704499, 704500, 704501, 704502, 704503, 704504, 704505, 704507, 704509, 704510, 704511, 704512, 704513, 704514, 704515, 704517, 704518, 704519, 704520, 704521, 704522, 704523, 704524, 704525, 704526, 704527, 704528, 704529, 704530, 704531, 704532, 704534, 704535, 704536, 704537, 704538, 704539, 704540, 704541, 704542, 704543, 704544, 704545, 704546, 704547, 704548, 704549, 704550, 704551, 704552, 704553, 704554, 704555, 704557, 704558, 704560, 704561, 704562, 704563, 704564, 704566, 704567, 704569, 704570, 704571, 704572, 704573, 704574, 704576, 704577, 704578, 704579, 704580, 704581, 704582, 704583, 704584, 704585, 704586, 704587, 704588, 704589, 704590, 704591, 704593, 704594, 704596, 704597, 704598, 704599, 704600, 704601, 704602, 704603, 704604, 704605, 704606, 704607, 704608, 704609, 704610, 704611, 704613, 704614, 704615, 704616, 704617, 704618, 704619, 704621, 704622, 704623, 704624, 704625, 704627, 704628, 704629, 704630, 704631, 704632, 704633, 704634, 704635, 704636, 704637, 704640, 704641, 704642, 704643, 704644, 704645, 704646, 704649, 704650, 704652, 704653, 704654, 704658, 704659, 704661, 704662, 704663, 704664, 704665, 704667, 704668, 704670, 704672, 704673, 704674, 704675, 704676, 704677, 704678, 704679, 704680, 704682, 704683, 704684, 704685, 704687, 704688, 704690, 704691, 704692, 704693. 704694, 704695, 704697, 704698, 704699, 704700, 704701, 704702, 704703, 704704, 704705, 704706, 704708, 704710, 704711, 704712, 704713, 704714, 704716, 704718, 704719, 704720, 704721, 704722, 704724, 704725, 704726, 704728, 704729, 704731, 704733, 704735, 704737, 704738, 704739, 704740, 704742, 704743, 704744, 704747, 704748, 704749, 704750, 704751, 704752, 704753, 704754, 704757, 704758, 704761, 704762, 704763, 704764, 704765, 704766, 704767, 704768, 704769, 704770, 704773, 704774, 704776, 704779, 704780, 704781, 704782, 704783, 704784, 704786, 704788, 704791, 704792, 704793, 704794, 704795, 704796, 704797, 704798, 704800, 704801, 704803, 704804, 704807, 704808, 704809, 704810, 704811, 704814, 704815, 704816, 704817, 704818, 704819, 704820, 704821, 704822, 704823, 704824, 704825, 704827, 704829, 704830, 704831, 704832, 704833, 704834, 704835, 704837, 704838, 704839, 704840, 704842, 704843, 704844, 704845, 704847, 704848, 704849, 704850, 704851, 704852, 704853, 704854, 704857, 704858, 704859, 704860, 704861, 704862, 704864, 704865, 704866, 704867, 704868, 704869, 704870, 704871, 704872, 704873, 704874, 704875, 704876, 704877, 704878, 704879, 704880, 704881, 704882, 704883, 704884, 704885, 704886, 704887, 704888, 704889, 704890, 704891, 704892, 704894, 704895,

Distribution pattern

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