Z-1278-2021 Class II Terminated
FDA device recall Z-1278-2021 was initiated by Baxter Healthcare Corporation on January 28, 2021 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 13, 2024). Affected quantity: 1225 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- January 28, 2021
- Termination Date
- June 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1225 units
Product Description
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Reason for Recall
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.
Distribution Pattern
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.
Code Information
GTIN 07332414105266 (product code 11308), serial numbers PA9946, PA9945, PA9939, PA9938, PA9936, PA9935, PA9934, PA9933, PA9932, PA9931, PA9930, PA9929, PA9928, PA9926, PA9925, PA9924, PA9923, PA9922, PA9921, PA9920, PA9919, PA9918, PA9917, PA9916, PA9915, PA9914, PA9913, PA9912, PA9907, PA9813, PA9804, PA9803, PA9801, PA9800, PA9799, PA9798, PA9797, PA9796, PA9793, PA9792, PA9791, PA9786, PA9784, PA9724, PA9723, PA9714, PA9713, PA9712, PA9711, PA9709, PA9703, PA9680, PA9675, PA9674, PA9669, PA9668, PA9667, PA9666, PA9665, PA9664, PA9663, PA9662, PA9661, PA9660, PA9659, PA9658, PA9657, PA9656, PA9655, PA9654, PA9653, PA9646, PA9606, PA9605, PA9604, PA9603, PA9601, PA9600, PA9599, PA9598, PA9597, PA9595, PA9594, PA9593, PA9592, PA9591, PA9590, PA9589, PA9586, PA9585, PA9582, PA9581, PA9579, PA9238, PA9216, PA9215, PA9213, PA9209, PA9208, PA9205, PA9204, PA9201, PA9199, PA9141, PA9128, PA9122, PA9121, PA9120, PA9119, PA9117, PA9114, PA9061, PA9039, PA9032, PA9028, PA9027, PA9026, PA9025, 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PA8667, PA8666, PA8665, PA8664, PA8663, PA8661, PA8657, PA8656, PA8654, PA8653, PA8652, PA8649, PA8648, PA8647, PA8647, PA8646, PA8645, PA8644, PA8643, PA8642, PA8640, PA8639, PA8638, PA8637, PA8636, PA8635, PA8634, PA8633, PA8632, PA8629, PA8615, PA8612, PA8611, PA8610, PA8609, PA8608, PA8607, PA8606, PA8605, PA8604, PA8603, PA8602, PA8601, PA8600, PA8597, PA8596, PA8589, PA8471, PA8466, PA15698, PA15697, PA15696, PA15695, PA15694, PA15693, PA15692, PA15691, PA15690, PA15689, PA15688, PA15687, PA15686, PA15685, PA15684, PA15683, PA15682, PA15681, PA15680, PA15679, PA15677, PA15676, PA15675, PA15674, PA15673, PA15672, PA15671, PA15670, PA15665, PA15664, PA15662, PA15661, PA15659, PA15658, PA15657, PA15656, PA15655, PA15654, PA15653, PA15652, PA15651, PA15650, PA15649, PA15642, PA15641, PA15640, PA15639, PA15638, PA15636, PA15634, PA15502, PA15501, PA15500, PA15498, PA15497, PA15495, PA15494, PA15493, PA15492, PA15490, PA15473, PA15461, PA15460, PA15458, PA15454, PA15453, PA15451, PA15449, PA15448, PA15444, PA15424, PA15414, PA15413, PA15412, PA15408, PA15407, PA15406, PA15404, PA15403, PA15400, PA15299, PA15298, PA15297, PA15288, PA15287, PA15286, PA15285, PA15284, PA15283, PA15282, PA15280, PA15279, PA15278, PA15276, PA15275, PA15274, PA15272, PA15271, PA15270, PA15269, PA15268, PA15267, PA15265, PA15264, PA15263, PA15255, PA15251, PA15250, PA15249, PA15244, PA15243, PA15242, PA15241, PA15240, PA15239, PA15238, PA15237, PA15236, PA15235, PA15234, PA15233, PA15232, PA15231, PA15229, PA15228, PA14638, PA14635, PA14612, PA14606, PA14605, PA14591, PA14590, PA14585, PA14584, PA14582, PA14581, PA14579, PA14578, PA14577, PA14575, PA14574, PA14573, PA14572, PA14571, PA14570, PA14568, PA14567, PA14566, PA14563, PA14560, PA14558, PA14556, PA14539, PA14516, PA14515, PA14502, PA14501, PA14500, PA14493, PA14492, PA14491, PA14484, PA14483, PA14482, PA14481, PA14474, PA14473, PA14339, PA14335, PA14322, PA14301, PA14295, PA14290, PA14289, PA14284, PA14283, PA14282, PA14281, PA14280, PA14279, PA14278, PA14277, PA14276, PA14275, PA14274, PA14272, PA14271, PA14270, PA14268, PA14267, PA14266, PA14264, PA14263, PA14260, PA14259, PA14258, PA14253, PA14247, PA14246, PA14245, PA14244, PA14238, PA14237, PA14236, PA14235, PA14234, PA14233, PA14232, PA14231, PA14214, PA14213, PA14212, PA14111, PA14110, PA14097, PA14096, PA14092, PA14091, PA14090, PA14089, PA14088, PA14087, PA14086, PA14085, PA14082, PA14081, PA14080, PA14078, PA14077, PA14076, PA14075, PA14034, PA14025, PA14023, PA14022, PA14021, PA14020, PA14019, PA14018, PA14015, PA14014, PA14012, PA14011, PA14010, PA14007, PA14006, PA14005, PA14004, PA14003, PA14002, PA14001, PA14000, PA13999, PA13998, PA13992, PA13939, PA13931, PA13928, PA13927, PA13926, PA13923, PA13922, PA13921, PA13920, PA13919, PA13918, PA13917, PA13916, PA13915, PA13913, PA13912, PA13911, PA13910, PA13909, PA13907, PA13906, PA13049, PA13026, PA13018, PA13017, PA13015, PA13014, PA13010, PA13008, PA13007, PA13005, PA13004, PA13003, PA13002, PA13001, PA13000, PA12999, PA12998, PA12997, PA12996, PA12995, PA12994, PA12993, PA12992, PA12991, PA12990, PA12989, PA12988, PA12987, PA12986, PA12985, PA12984, PA12983, PA12982, PA12981, PA12980, PA12979, PA12978, PA12977, PA12976, PA12975, PA12974, PA12973, PA12971, PA12970, PA12969, PA12968, PA12967, PA12966, PA12965, PA12964, PA12962, PA12960, PA12959, PA12957, PA12956, PA12955, PA12954, PA12952, PA12951, PA12950, PA12949, PA12948, PA12947, PA12946, PA12945, PA12944, PA12943, PA12942, PA12940, PA12936, PA12833, PA12832, PA12828, PA12824, PA12808, PA12797, PA12796, PA12795, PA12794, PA12793, PA12792, PA12791, PA12790, PA12789, PA12788, PA12787, PA12786, PA12785, PA12784, PA12783, PA12376, PA12358, PA12353, PA12347, PA12346, PA12345, PA12344, PA12343, PA12342, PA12341, PA12340, PA12339, PA12338, PA12337, PA12336, PA12335, PA12334, PA12333, PA12332, PA12331, PA12330, PA12329, PA12328, PA12327, PA12325, PA12324, PA12321, PA12320, PA12320, PA12319, PA12318, PA12177, PA12165, PA12164, PA12149, PA12148, PA12147, PA12144, PA12142, PA12141, PA12140, PA12139, PA12138, PA12137, PA12136, PA12134, PA12133, PA12132, PA12131, PA12129, PA12128, PA12127, PA12126, PA12125, PA12124, PA12123, PA12122, PA12121, PA12119, PA12118, PA12117, PA12019, PA12008, PA12005, PA12004, PA12003, PA11996, PA11995, PA11994, PA11993, PA11992, PA11991, PA11990, PA11989, PA11987, PA11986, PA11986, PA11985, PA11984, PA11983, PA11982, PA11981, PA11980, PA11979, PA11978, PA11977, PA11976, PA11975, PA11974, PA11973, PA11972, PA11817, PA11776, PA11773, PA11772, PA11771, PA11768, PA11541, PA11527, PA11526, PA11520, PA11519, PA11518, PA11517, PA11516, PA11515, PA11513, PA11512, PA11511, PA11510, PA11505, PA11504, PA11503, PA11502, PA11501, PA11500, PA11499, PA11497, PA11496, PA11495, PA11494, PA11493, PA11492, PA11491, PA11490, PA11489, PA11392, PA11389, PA11382, PA11381, PA11380, PA11379, PA11377, PA11376, PA11375, PA11374, PA11372, PA11371, PA11370, PA11369, PA11368, PA11367, PA11366, PA11365, PA11364, PA11363, PA11362, PA11361, PA11360, PA11359, PA11358, PA11356, PA11355, PA11353, PA11260, PA11257, PA11251, PA11250, PA11249, PA11248, PA11247, PA11246, PA11245, PA11244, PA11243, PA11242, PA11241, PA11240, PA11239, PA11238, PA11237, PA11236, PA11235, PA11234, PA11231, PA11230, PA11228, PA11227, PA11226, PA11225, PA11224, PA11223, PA11222, PA11146, PA11145, PA11144, PA11143, PA11142, PA11141, PA11140, PA11139, PA11138, PA11137, PA11136, PA11135, PA11134, PA11133, PA11132, PA11131, PA11130, PA11129, PA11128, PA11127, PA11126, PA11125, PA11124, PA11123, PA11122, PA11121, PA11120, PA11119, PA11118, PA11117, PA11004, PA10993, PA10990, PA10989, PA10986, PA10985, PA10984, PA10983, PA10982, PA10981, PA10979, PA10978, PA10977, PA10976, PA10975, PA10974, PA10973, PA10972, PA10971, PA10970, PA10969, PA10968, PA10967, PA10966, PA10965, PA10964, PA10963, PA10962, PA10958, PA10957, PA10923, PA10919, PA10918, PA10917, PA10916, PA10915, PA10914, PA10913, PA10912, PA10911, PA10910, PA10909, PA10908, PA10907, PA10906, PA10905, PA10904, PA10903, PA10902, PA10901, PA10900, PA10899, PA10898, PA10897, PA10896, PA10895, PA10894, PA10893, PA10892, PA10891, PA10887, PA10870, PA10861, PA10860, PA10859, PA10847, PA10846, PA10845, PA10844, PA10843, PA10841, PA10838, PA10837, PA10836, PA10835, PA10834, PA10833, PA10832, PA10831, PA10830, PA10829, PA10828, PA10827, PA10823, PA10822, PA10821, PA10820, PA10819, PA10817, PA10816, PA10787, PA10786, PA10783, PA10782, PA10781, PA10780, PA10777, PA10776, PA10775, PA10774, PA10773, PA10772, PA10771, PA10770, PA10769, PA10768, PA10767, PA10766, PA10764, PA10763, PA10762, PA10761, PA10758, PA10757, PA10755, PA10754, PA10753, PA10751, PA10750, PA10749, PA10748, PA10695, PA10681, PA10680, PA10675, PA10674, PA10672, PA10671, PA10670, PA10669, PA10668, PA10667, PA10666, PA10665, PA10664, PA10663, PA10662, PA10661, PA10660, PA10659, PA10658, PA10657, PA10656, PA10655, PA10654, PA10653, PA10651, PA10650, PA10649, PA10648, PA10646, PA10645, PA10644, PA10643, 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PA10244, PA10239, PA10236, PA10235, PA10234, PA10233, PA10232, PA10231, PA10230, PA10229, PA10228, PA10227, PA10226, PA10225, PA10223, PA10222, PA10221, PA10220, PA10219, PA10218, PA10217, PA10216, PA10213, PA10211, PA10171, PA10165, PA10161, PA10160, PA10159, PA10158, PA10157, PA10156, PA10155, PA10154, PA10153, PA10152, PA10151, PA10150, PA10149, PA10148, PA10147, PA10146, PA10145, PA10144, PA10143, PA10142, PA10141, PA10140, PA10139, PA10138, PA10137, PA10136, PA10135, PA10134, PA10133, PA10132, PA10046, PA10042, PA10041, PA10040, PA10039, PA10038, PA10037, PA10036, PA10035, PA10034, PA10033, PA10030, PA10029, PA10028, PA10027, PA10026, PA10025, PA10024, PA10023, PA10022, PA10021, PA10020, PA10019, PA10018, PA10017, PA10016, PA10015, PA10014, PA10013, PA10011, PA10010, PA10009, PA10008.