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Prismaflex recallZ-1279-2021 · Baxter Healthcare Corporation · initiated Jan 28, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

FDA root cause category: Process control

What the company is doing

An Urgent Medical Device Correction communication and reply form were sent to affected customers via U.S.P.S., first class mail on January 28, 2021.

Recall details

Recall number
Z-1279-2021
Status
Terminated
Initiated by the company
Jan 28, 2021
Recalling firm
Baxter Healthcare Corporation
Quantity
1650 units
Product code
KDI
FDA submissions
K131516
Distribution
Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Malta, Mauritius, Montenegro, Morocco, Netherlands, Nigeria, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Syria, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Yemen, Australia, New Zealand, China, Japan, Korea, Taiwan, Hong Kong, India, Thailand, Singapore, Malaysia, Vietnam, Grand Cayman, Dominican Republic, St. Kitts, Venezuela, Argentina, Chile, Barbados, Bermuda, Costa Rica, Cuba, Haiti, Guatemala, Colombia, Trinidad & Tobago, Mexico, and Brazil.

Product description

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Code information (models, lots, serial numbers)

Show the full code information (15k characters)

GTIN 07332414117702 (product code 115269), serial numbers PA18954, PA18949, PA18948, PA18947, PA18946, PA18945, PA18944, PA18943, PA18941, PA18939, PA18937, PA18936, PA18935, PA18934, PA18932, PA18931, PA18930, PA18927, PA18926, PA18925, PA18924, PA18923, PA18922, PA18920, PA18919, PA18918, PA18915, PA18913, PA18911, PA18894, PA18893, PA18892, PA18889, PA18888, PA18887, PA18886, PA18885, PA18884, PA18883, PA18882, PA18881, PA18879, PA18836, PA18828, PA18802, PA18800, PA18799, PA18797, PA18796, PA18795, PA18794, PA18793, PA18792, PA18791, PA18790, PA18788, PA18787, PA18786, PA18785, PA18784, PA18782, PA18781, PA18780, PA18778, PA18774, PA18757, PA18736, PA18729, PA18726, PA18722, PA18721, PA18720, PA18719, PA18718, PA18717, PA18716, PA18714, PA18713, PA18712, PA18711, PA18710, PA18706, PA18705, PA18701, PA18700, PA18699, PA18687, PA18679, PA18678, PA18677, PA18676, PA18675, PA18674, PA18673, PA18672, PA18671, PA18670, PA18669, PA18668, PA18667, PA18664, PA18662, PA18661, PA18660, PA18659, PA18624, PA18619, PA18617, PA18616, PA18612, PA18610, PA18609, PA18608, PA18604, PA18603, PA18601, PA18600, PA18599, PA18598, PA18597, PA18595, PA18594, PA18593, PA18592, PA18590, PA18252, PA18247, PA18240, PA18235, PA18232, PA18231, PA18230, PA18229, PA18228, PA18227, PA18226, PA18225, PA18223, PA18222, PA18221, PA18219, PA18218, PA18217, PA18209, PA18208, PA18180, PA18179, PA18169, PA18168, PA18167, PA18157, PA18156, PA18155, PA18154, PA18153, PA18152, PA18151, PA18150, PA18149, PA18147, PA18146, PA18145, PA18144, PA18143, PA18142, PA18141, PA18137, PA18005, PA17992, PA17991, PA17990, PA17987, PA17986, PA17985, PA17984, PA17983, PA17982, PA17981, PA17980, PA17979, PA17978, PA17977, PA17976, PA17975, PA17972, PA17970, PA17969, PA17965, PA17795, PA17782, PA17767, PA17766, PA17750, PA17749, PA17747, PA17746, PA17745, PA17744, PA17743, PA17741, PA17740, PA17739, PA17735, PA17733, PA17732, PA17731, PA17730, PA17717, PA17716, PA17715, PA17714, PA17712, PA17709, PA17708, PA17707, PA17706, PA17705, PA17704, PA17699, PA17698, PA17697, PA17694, PA17693, PA17692, PA17691, PA17690, PA17689, PA17688, PA17687, PA17684, PA17683, PA17682, PA17678, PA17677, PA17676, PA17671, PA17669, PA17668, PA17667, PA17666, PA17665, PA17662, PA17661, PA17657, PA17656, PA17653, PA17642, PA17639, PA17638, PA17634, PA17633, PA17632, PA17621, PA17620, PA17619, PA17618, PA17617, PA17615, PA17614, PA17613, PA17612, PA17611, PA17609, PA17608, PA17607, PA17597, PA17596, PA17595, PA17594, PA17593, PA17565, PA17564, PA17563, PA17562, PA17561, PA17560, PA17559, PA17558, PA17557, PA17556, PA17555, PA17554, PA17552, PA17551, PA17550, PA17549, PA17547, PA17546, PA17545, PA17543, PA17478, PA17476, PA17473, PA17471, PA17438, PA17429, PA17428, PA17427, PA17425, PA17424, PA17423, PA17422, PA17421, PA17417, PA17416, PA17415, PA17414, PA17412, PA17411, PA17378, PA17371, PA17370, PA17365, PA17358, PA17357, PA17356, PA17355, PA17354, PA17352, PA17351, PA17350, PA17349, PA17347, PA17346, PA17345, PA17344, PA17343, PA17342, PA17341, PA17340, PA17339, PA17338, PA17337, PA17336, PA17335, PA17322, PA17320, PA17319, PA17318, PA17317, PA17316, PA17315, PA17314, PA17313, PA17312, PA17311, PA17310, PA17309, PA17308, PA17307, PA17306, PA17305, PA17300, PA17299, PA17298, PA17289, PA17287, PA17286, PA17285, PA17284, PA17283, PA17281, PA17276, PA17275, PA17215, PA17115, PA17113, PA17110, PA17109, PA17108, PA17106, PA17105, PA17104, PA17103, PA17102, PA17101, PA17100, PA17099, PA17098, PA17096, PA17095, PA17094, PA17093, PA17092, PA17091, PA17073, PA17051, PA17050, PA17049, PA17048, PA17047, PA17046, PA17045, PA17044, PA17043, PA17042, PA17041, PA17040, PA17039, PA17038, PA17037, PA17035, PA17034, PA17033, PA17031, PA17030, PA16839, PA16832, PA16831, PA16830, PA16829, PA16828, PA16826, PA16825, PA16823, PA16822, PA16821, PA16795, PA16767, PA16763, PA16762, PA16761, PA16760, PA16759, PA16758, PA16757, PA16756, PA16586, PA16585, PA16582, PA16580, PA16579, PA16578, PA16577, PA16576, PA16571, PA16442, PA16436.PA16435, PA16433, PA16432, PA16431, PA16430, PA16429, PA16428, PA16427, PA16426, PA16292, PA16276, PA16275, PA16274, PA16273, PA16272, PA16271, PA16270, PA16269, PA16268, PA16267, PA16266, PA16265, PA16264, PA16263, PA16262, PA16261, PA16260, PA16257, PA16256, PA16255, PA16174, PA16173, PA16172, PA16171, PA16170, PA16169, PA16168, PA16167, PA16166, PA16165, PA16164, PA16163, PA16162, PA16161, PA16160, PA16159, PA16158, PA16157, PA16156, PA16155, PA16154, PA16153, PA16152, PA16151, PA16150, PA16149, PA16148, PA16147, PA16146, PA16145, PA16144, PA16098, PA16097, PA16095, PA16094, PA16093, PA16092, PA16091, PA16090, PA16089, PA16088, PA16087, PA16086, PA16085, PA16084, PA15991, PA15990, PA15989, PA15988, PA15987, PA15985, PA15984, PA15983, PA15982, PA15981, PA15978, PA15972, PA15971, PA15970, PA15969, PA15968, PA15967, PA15966, PA15965, PA15964, PA15963, PA15890, PA15889, PA15888, PA15887, PA15886, PA15884, PA15883, PA15882, PA15881, PA15880, PA15879, PA15878, PA15877, PA15876, PA15875, PA15874, PA15873, PA15872, PA15871, PA15870, PA15869; GTIN 07332414124236 (product code 955542), serial numbers PA20340, PA20298, PA20297, PA20296, PA20291, PA20290, PA20289, PA20288, PA20287, PA20286, PA20284, PA20283, PA20282, PA20280, PA20279, PA20278, PA20277, PA20276, PA20275, PA20274, PA20273, PA20272, PA20271, PA20270, PA20269, PA20268, PA20267, PA20266, PA20265, PA20264, PA20263, PA20262, PA20261, PA20260, PA20259, PA20258, PA20252, PA20247, PA20246, PA20245, PA20244, PA20243, PA20190, PA20189, PA20188, PA20187, PA20179, PA20178, PA20177, PA20176, PA20175, PA20174, PA20173, PA20172, PA20171, PA20170, PA20169, PA20168, PA20167, PA20166, PA20165, PA20163, PA20146, PA20135, PA20134, PA20133, PA20132, PA20131, PA20130, PA20129, PA20128, PA20127, PA20126, PA20125, PA20124, PA20123, PA20122, PA20121, PA20120, PA20119, PA20118, PA20117, PA20115, PA20114, PA20113, PA20112, PA20111, PA20110, PA20109, PA20108, PA20107, PA20106, PA20105, PA20104, PA20102, PA20101, PA20100, PA20099, PA20098, PA20097, PA20096, PA20095, PA20094, PA20091, PA19895, PA19894, PA19893, PA19892, PA19888, PA19885, PA19884, PA19883, PA19879, PA19878, PA19877, PA19872, PA19866, PA19865, PA19859, PA19858, PA19857, PA19856, PA19855, PA19853, PA19647, PA19646, PA19645, PA19644, PA19643, PA19642, PA19641, PA19640, PA19639, PA19638, PA19637, PA19636, PA19635, PA19634, PA19633, PA19632, PA19631, PA19630, PA19629, PA19628, PA19625, PA19556, PA19537, PA19536, PA19535, PA19534, PA19533, PA19528, PA19527, PA19526, PA19525, PA19524, PA19523, PA19522, PA19518, PA19517, PA19516, PA19515, PA19514, PA19513, PA19512, PA19510, PA19507, PA19282, PA19279, PA19261, PA19260, PA19259, PA19258, PA19257, PA19256, PA19255, PA19254, PA19253, PA19252, PA19251, PA19250, PA19249, PA19248, PA19247, PA19244, PA19243, PA19239, PA19223, PA19222, PA19221, PA19220, PA19219, PA19218, PA19216, PA19214, PA19213, PA19212, PA19211, PA19210, PA19209, PA19208, PA19207, PA19206, PA19205, PA19204, PA19203, PA19202, PA19201, PA19200, PA19199, PA19198, PA19197, PA19195, PA19193, PA19192, PA19191, PA19189, PA19188, PA18916, PA18906, PA18903, PA18902, PA18900, PA18899, PA18898, PA18897, PA18896, PA18895, PA22643, PA22642, PA22634, PA22633, PA22625, PA22624, PA22587, PA22582, PA22575, PA22574, PA22573, PA22570, PA22569, PA22568, PA22567, PA22566, PA22565, PA22559, PA22557, PA22555, PA22554, PA22553, PA22552, PA22551, PA22550, PA22548, PA22547, PA22546, PA22545, PA22544, PA22543, PA22542, PA22541, PA22540, PA22539, PA22536, PA22535, PA22534, PA22533, PA22532, PA22531, PA22530, PA22529, PA22528, PA22527, PA22526, PA22525, PA22524, PA22523, PA22522, PA22521, PA22519, PA22517, PA22516, PA22515, PA22514, PA22513, PA22511, PA22510, PA22509, PA22508, PA22507, PA22185, PA21815, PA21782, PA21767, PA21747, PA21730, PA21727, PA21726, PA21722, PA21720, PA21719, PA21718, PA21717, PA21716, PA21715, PA21714, PA21713, PA21712, PA21710, PA21709, PA21708, PA21707, PA21675, PA21667, PA21666, PA21665, PA21655, PA21654, PA21649, PA21648, PA21647, PA21646, PA21645, PA21644, PA21643, PA21642, PA21641, PA21640, PA21639, PA21638, PA21637, PA21636, PA21635, PA21634, PA21633, PA21632, PA21631, PA21630, PA21629, PA21628, PA21627, PA21626, PA21625, PA21624, PA21623, PA21621, PA21620, PA21619, PA21618, PA21617, PA21616, PA21614, PA21613, PA21610, PA21609, PA21608, PA21605, PA21601, PA21598, PA21597, PA21596, PA21595, PA21594, PA21593, PA21592, PA21589, PA21588, PA21587, PA21585, PA21584, PA21583, PA21582, PA21581, PA21580, PA21482, PA21481, PA21472, PA21469, PA21461, PA21460, PA21459, PA21458, PA21457, PA21456, PA21455, PA21454, PA21453, PA21452, PA21451, PA21450, PA21449, PA21448, PA21446, PA21445, PA21444, PA21404, PA21394, PA21334, PA21332, PA21331, PA21330, PA21329, PA21328, PA21324, PA21323, PA21322, PA21321, PA21320, PA21319, PA21318, PA21317, PA21316, PA21315, PA21313, PA21306, PA21305, PA21244, PA21243, PA21242, PA21238, PA21235, PA21234, PA21233, PA21232, PA21231, PA21230, PA21229, PA21226, PA21222, PA21221, PA21220, PA21219, PA21218, PA21217, PA21214, PA21213, PA21212, PA21191, PA21163, PA21162, PA21160, PA21148, PA21147, PA21146, PA21145, PA21144, PA21143, PA21142, PA21141, PA21140, PA21139, PA21138, PA21137, PA21136, PA21135, PA21134, PA21133, PA21132, PA21129, PA21114, PA21108, PA21101, PA21098, PA21095, PA21094, PA21093, PA21092, PA21091, PA21090, PA21089, PA21088, PA21086, PA21085, PA21083, PA21082, PA21081, PA21080, PA21074, PA21072, PA21047, PA21045, PA21041, PA21040, PA21039, PA21037, PA21036, PA21035, PA21034, PA21033, PA21032, PA21031, PA21028, PA21027, PA21024, PA21023, PA21022, PA21016, PA21015, PA21014, PA21007, PA20868, PA20867, PA20866, PA20865, PA20864, PA20863, PA20862, PA20861, PA20860, PA20859, PA20858, PA20857, PA20856, PA20855, PA20854, PA20853, PA20852, PA20851, PA20846, PA20845, PA20844, PA20754, PA20748, PA20746, PA20745, PA20741, PA20740, PA20738, PA20737, PA20732, PA20731, PA20730, PA20729, PA20728, PA20727, PA20726, PA20725, PA20724, PA20723, PA20722, PA20718, PA20716, PA20692, PA20691, PA20690, PA20677, PA20668, PA20664, PA20661, PA20660, PA20658, PA20657, PA20656, PA20655, PA20654, PA20653, PA20652, PA20651, PA20650, PA20649, PA20648, PA20646, PA20643, PA20642, PA20641, PA20640, PA20629, PA20625, PA20624, PA20623, PA20622, PA20621, PA20620, PA20619, PA20618, PA20617, PA20613, PA20612, PA20611, PA20610, PA20609, PA20608, PA20606, PA20605, PA20530, PA20524, PA20523, PA20522, PA20521, PA20520, PA20519, PA20518, PA20517, PA20516, PA20515, PA20514, PA20513, PA20512, PA20511, PA20509, PA20508, PA20507, PA20506, PA20503, PA20502, PA20501, PA20490, PA20484, PA20483, PA20482, PA20481, PA20478, PA20477, PA20476, PA20475, PA20474, PA20472, PA20471, PA20470, PA20458, PA20448, PA20446, PA20445, PA20443, PA20442, PA20441;  GTIN 07332414126766 (product code 955792), serial numbers PA23509, PA23510, PA23512, PA23513, PA23519, PA32437, PA32438, PA32435, PA32436, PA32404, PA32405, PA32406, PA32407, PA32408, PA32409, PA32410, PA32411, PA32412, PA32414, PA32415, PA32417, PA32418, PA32419, PA32420, PA32421, PA32422, PA32423, PA32331, PA32332, PA32333, PA32334, PA32335, PA32336, PA32337, PA32338, PA32339, PA32340, PA32341, PA32342, PA32343, PA31628, PA31629, PA31630, PA31631, PA31632, PA31555, PA31556, PA31557, PA31558, PA31559, PA31560, PA31561, PA31562, PA31563, PA31564, PA31164, PA31165, PA31166, PA31167, PA31168, PA31169, PA31170, PA31171, PA31172, PA31173, PA31174, PA31175, PA31176, PA31177, PA31178, PA31179, PA31180, PA31181, PA31182, PA31183, PA31184, PA31185, PA31186, PA31187, PA31188, PA31189, PA31190, PA31191, PA31192, PA31193, PA31194, PA31195, PA31196, PA31197, PA31198, PA31199, PA31200, PA31201, PA31202, PA31203, PA31204, PA31205, PA31206, PA31207, PA31208, PA31209, PA31210, PA31211, PA31212, PA31213, PA31214, PA31215, PA31216, PA31217, PA31218, PA31219, PA31220, PA31221, PA31222, PA31223, PA30980, PA30981, PA30982, PA30983, PA30984, PA30985, PA30986, PA30987, PA30988, PA30989, PA30990, PA30991, PA30992, PA30993, PA30994, PA30995, PA30996, PA30997, PA30998, PA30999, PA30896, PA30897, PA30898, PA30899, PA30900, PA30901, PA30902, PA30903, PA30904, PA30905, PA30906, PA30907, PA30908, PA30909, PA30910, PA30911, PA30912, PA30913, PA30914, PA30915, PA30916, PA30917, PA30918, PA30919, PA30920, PA30921, PA30922, PA30923, PA30924, PA30925, PA30926, PA30927, PA30928, PA30929, PA30930, PA30931, PA30932, PA30933, PA30934, PA30935, PA30812, PA30813, PA30814, PA30815, PA30816, PA30817, PA30818, PA30819, PA30820, PA30821, PA30822, PA30823, PA30770, PA30771, PA23509, PA23510, PA23512, PA23513, PA23519, PA30041, PA30042, PA30043, PA30044, PA30045, PA30391, PA30392, PA30393, PA30394, PA30395, PA30396, PA30397, PA30398, PA30399, PA30400, PA30401, PA30402, PA30403, PA30404, PA30405, PA30406, PA30407, PA30408, PA30409, PA30410, PA30552, PA30553, PA30554, PA30555, PA30556, PA30557, PA30558, PA30559, PA30560, PA30561, PA30696, PA30697, PA30704, PA30705, PA30706, PA30707, PA30708, PA30709, PA30710, PA30711, PA30712, PA30713, PA30714, PA30715, PA30716, PA30717, PA30552, PA30553, PA30554, PA30555, PA30556, PA30557, PA30558, PA30559, PA30560, PA30561, PA30391, PA30392, PA30393, PA30394, PA30395, PA30396, PA30397, PA30398, PA30399, PA30400, PA30401, PA30402, PA30403, PA30404, PA30405, PA30406, PA30407, PA30408, PA30409, PA30410, PA23481, PA23482, PA23483, PA23484, PA23485, PA23486, PA23487, PA23488, PA23489, PA23490, PA23491, PA23492, PA23493, PA23494, PA23480, PA23470, PA23471, PA23472, PA23476, PA23477, PA23478, PA30041, PA30042, PA30043, PA30044, PA30045, PA23226, PA23218, PA23219, PA23220, PA23221, PA23222, PA23223, PA23212, PA23213, PA23214, PA23215, PA23216, PA23217, PA23206, PA23207, PA23208, PA23209, PA23201, PA23205, PA23182, PA23181, PA23183, PA23184, PA23180, PA23185, PA23174, PA23167, PA23175, PA23176, PA23161, PA23163, PA23160, PA23156, PA23157, PA23158, PA23159, PA23162, PA23154, PA23151, PA23152, PA23153, PA23150, PA23120, PA23114, PA23115, PA23125, PA23116, PA23107, PA23108, PA23106, PA23109, PA23110, PA23111, PA23112, PA23113, PA23102, PA23103, PA23104, PA23096, PA23100, PA23099, PA23101, PA23094, PA23085, PA23076, PA23070, PA23071, PA23072, PA23073, PA23074, PA23075, PA23065, PA23066, PA23068, PA23069, PA23058, PA23059, PA23060, PA23062, PA23063, PA23053, PA23055, PA23056, PA23057, PA23050, PA23041, PA23018, PA23019, PA23020, PA23021, PA23022, PA23014, PA23015, PA23016, PA23006, PA23007, PA23008, PA23011, PA22999, PA23000, PA23002, PA23003, PA23004, PA23005, PA22996, PA22983, PA22984, PA22966, PA22959, PA22960, PA22961, PA22962, PA22946, PA22949, PA22953, PA22954, PA22956, PA22957, PA22958, PA22955, PA22945, PA22948, PA22950, PA22951, PA22952, PA22941, PA22944, PA22937, PA22938, PA22921, PA22922, PA22911, PA22912, PA22909, PA22910, PA22914, PA22915, PA22913, PA22902, PA22903, PA22904, PA22906, PA22907, PA22898, PA22899, PA22900, PA22901, PA22867, PA22868, PA22869, PA22870, PA22871, PA22872, PA22874, PA22876, PA22877, PA22880, PA22884, PA22875, PA22873, PA22782, PA22784, PA22786, PA22787, PA22783, PA22862, PA22860, PA22861.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 87299).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page