Baxter Healthcare Corporation Recall 87299
Description: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation Recall 87299 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1278-2021 |
| Event ID | 87299 |
| Event Description | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). |
| Product Type | Devices |
| 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. |
| Quantity | 1225 units |
| Recall Reason | 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. |
| Device Classification | 20210331 |
| Device Code Info | 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, PA9024, PA9023, PA9022, PA8963, PA8951, PA8950, PA8949, PA8948, PA8928, PA8925, PA8924, PA8920, PA8917, PA8916, PA8915, PA8914, PA8913, PA8912, PA8911, PA8910, PA8909, PA8908, PA8904, PA8899, PA8898, PA8883, PA8882, PA8878, PA8874, PA8873, PA8872, PA8871, PA8868, PA8867, PA8865, PA8861, PA8857, PA8851, PA8850, PA8849, PA8848, PA8847, PA8845, PA8844, PA8843, PA8842, PA8840, PA8839, PA8804, PA8803, PA8798, PA8797, PA8792, PA8791, PA8790, PA8789, PA8788, PA8774, PA8768, PA8767, PA8766, PA8765, PA8764, PA8763, PA8762, PA8761, PA8760, PA8759, PA8758, PA8757, PA8756, PA8755, PA8752, PA8751, PA8750, PA8749, PA8748, PA8747, PA8745, PA8744, PA8743, PA8742, PA8741, PA8740, PA8739, PA8737, PA8736, PA8735, PA8734, PA8733, PA8732, PA8732, PA8731, PA8730, PA8728, PA8725, PA8717, PA8716, PA8709, PA8708, PA8703, PA8702, PA8701, PA8699, PA8698, PA8697, PA8696, PA8695, PA8694, PA8692, PA8691, PA8688, PA8687, PA8686, PA8685, PA8684, PA8683, PA8682, PA8681, PA8680, PA8677, PA8672, PA8670, PA8669, PA8668, 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, PA10641, PA10640, PA10639, PA10637, PA10636, PA10633, PA10632, PA10631, PA10630, PA10629, PA10628, PA10627, PA10626, PA10625, PA10624, PA10623, PA10622, PA10621, PA10620, PA10619, PA10618, PA10617, PA10614, PA10613, PA10612, PA10611, PA10610, PA10609, PA10563, PA10530, PA10514, PA10507, PA10506, PA10504, PA10503, PA10502, PA10500, PA10499, PA10497, PA10496, PA10441, PA10431, PA10429, PA10428, PA10426, PA10425, PA10424, PA10423, PA10421, PA10420, PA10419, PA10418, PA10417, PA10416, PA10415, PA10414, PA10413, PA10411, PA10410, PA10409, PA10365, PA10363, PA10351, PA10350, PA10349, PA10348, PA10347, PA10346, PA10345, PA10343, PA10342, PA10341, PA10340, PA10339, PA10338, PA10337, PA10336, PA10335, PA10334, PA10331, PA10330, PA10329, PA10320, PA10318, PA10317, PA10316, PA10315, PA10314, PA10313, PA10312, PA10310, PA10309, PA10308, PA10307, PA10306, PA10305, PA10303, PA10302, PA10301, PA10300, PA10298, PA10297, PA10296, PA10295, PA10294, PA10292, PA10291, PA10290, PA10289, PA10288, PA10256, 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. |
| Center Classification Date | 20210319 |
| Recall Initiation Date | 20210128 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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