Prismaflex recallZ-1278-2021 · Baxter Healthcare Corporation · initiated Jan 28, 2021
Terminated
Is my device affected?
- 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.
- 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.
- 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-1278-2021
- Status
- Terminated
- Initiated by the company
- Jan 28, 2021
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1225 units
- Product code
- KDI
- FDA submissions
- K110823
- 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 (11k characters)
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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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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Prismaflex 5.XXGambro AB · Dialyzer, high permeability with or without sealed dialysate system3 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87299).
- Z-1279-2021 · TerminatedPrismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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