Z-1278-2021Class II

Prismaflex Control Unit -

Name: Z-1278-2021 Prismaflex Control Unit -
Creator: Baxter Healthcare Corporation
Published: 2021-01-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-01-28 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT) on 2021-01-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1278-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-28
Posted: 2021-03-19
Terminated: 2024-06-13
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1225 units
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 codes and lots: 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, 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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, 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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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1278-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1277-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19
Z-1278-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19
Z-1279-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19
Z-1280-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19

Product code KDI

K110823Class IIPrismaflexGambro Renal Products, Inc. / cleared 2011-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)