—#185767

Product

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

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K110823
Affected lot / 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, 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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, 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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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2021-01-28
Terminated: 2024-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185767. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.