Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling approximately 1,650 Prismaflex Control Units used for continuous renal replacement therapy. The recalled units have variability in tubing performance in the Automatic Repositioning System (ARPS) Pump Assembly that may cause alarm situations during or after a system self-test. The affected devices are identified by product code 115269 and specific serial numbers beginning with "PA18" and "PA17." The devices have been distributed worldwide, including throughout the United States, Puerto Rico, Guam, and numerous countries in Europe, the Middle East, Africa, and Asia.
The source document does not specify a remedy or corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Quantity: 1650 units Lot/code info: GTIN 07332414117702 (product code 115269), serial numbers PA18954, PA18949, PA18948, PA18947, PA18946, PA18945, PA18944, PA18943, PA18941, PA18939, PA18937, PA18936, PA18935, PA18934, PA18932, PA18931, PA18930, PA18927, PA18926, PA18925, PA18924, PA18923, PA18922, PA18920, PA18919, PA18918, PA18915, PA18913, PA18911, PA18894, PA18893, PA18892, PA18889, PA18888, PA18887, PA18886, PA18885, PA18884, PA18883, PA18882, PA18881, PA18879, PA18836, PA18828, PA18802, PA18800, PA18799, PA18797, PA18796, PA18795, PA18794, PA18793, PA18792, PA18791, PA18790, PA18788, PA18787, PA18786, PA18785, PA18784, PA18782, PA18781, PA18780, PA18778, PA18774, PA18757, PA18736, PA18729, PA18726, PA18722, PA18721, PA18720, PA18719, PA18718, PA18717, PA18716, PA18714, PA18713, PA18712, PA18711, PA18710, PA18706, PA18705, PA18701, PA18700, PA18699, PA18687, PA18679, PA18678, PA18677, PA18676, PA18675, PA18674, PA18673, PA18672, PA18671, PA18670, PA18669, PA18668, PA18667, PA18664, PA18662, PA18661, PA18660, PA18659, PA18624, PA18619, PA18617, PA18616, PA18612, PA18610, PA18609, PA18608, PA18604, PA18603, PA18601, PA18600, PA18599, PA18598, PA18597, PA18595, PA18594, PA18593, PA18592, PA18590, PA18252, PA18247, PA18240, PA18235, PA18232, PA18231, PA18230, PA18229, PA18228, PA18227, PA18226, PA18225, PA18223, PA18222, PA18221, PA18219, PA18218, PA18217, PA18209, PA18208, PA18180, PA18179, PA18169, PA18168, PA18167, PA18157, PA18156, PA18155, PA18154, PA18153, PA18152, PA18151, PA18150, PA18149, PA18147, PA
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.