Recall Z-1278-2021 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
| Date | Jan 28, 2021 |
| Status | Terminated |
| Reason | 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 | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110823 | PRISMAFLEX Gambro Renal Products, Inc., Jun 17, 2011 |