Recall Z-0169-2007 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
| Date | Nov 14, 2006 (initiated Sep 6, 2006) |
| Status | Terminated |
| Reason | The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute |
| Quantity | 2,823 units |
| Distribution | Nationwide and Hong Kong, Korea and China |
| 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 |