Recall Z-0947-05 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
| Date | Jun 30, 2005 (initiated Oct 3, 2003) |
| Status | Terminated |
| Reason | The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system. |
| Root cause | Other |
| Action | No official recall notificaiton was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003. |
| Quantity | 2986 units |
| Distribution | Nationwide, Korea, Mexico, Guatemala, China and Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992894 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 Baxter Healthcare Corp, Nov 24, 1999 |