Recall Z-0758-04 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 | Jul 20, 2004 (initiated Mar 10, 2004) |
| Status | Terminated |
| Reason | Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2. Baxter developed a permanent fix - |
| Quantity | 2,949 units |
| Distribution | Nationwide, Mexico, China and Korea. |
| 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 |