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 1,225 units of the Prismaflex Control Unit used for continuous renal replacement therapy. The recall affects units with product code 11308 and specific serial numbers distributed worldwide, including throughout the United States, Puerto Rico, Guam, and numerous countries across Europe, Africa, and Asia.
The recall is due to variability in tubing performance in the device's Automatic Repositioning System Pump Assembly that may cause alarm situations during or after a system self-test. The recall source does not specify a remedy or actions consumers should 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: 1225 units 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, 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, PA8
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.