Recall Z-0299-05 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 | Dec 8, 2004 (initiated Dec 2, 2004) |
| Status | Terminated |
| Reason | The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 12/2/04 to all Meridian customers on the same date. The letters informed the accounts of the potential for disconnection of the power cord and teh potential for arcing, fire or electrical shock. The accounts were requested to examine their instruments to see if a new power cord clamp has been installed on the unit, using the enclosed instructions and complete the enclosed reply sheet indicating the number of units already corrected, and the number of units still requiring the power cord clamp. The accounts were requested to fax the complete |
| Quantity | 3,004 units |
| Distribution | Nationwide and internationally to 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 |