Recall Z-0275-06 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 14, 2005 (initiated Sep 28, 2005) |
| Status | Terminated |
| Reason | Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury. |
| Root cause | Other |
| Action | Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams |
| Quantity | 2,838 units |
| Distribution | Nationwide and internationally to Mexico and Asia. |
| 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 |