Recall Z-0901-04 ยท KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Baxter Healthcare Renal Div
Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
| Date | Jul 20, 2004 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 4/12/04 to the attention of the Dialysis Unit Administrator. Separate letters were sent to the Renalsoft customers and to the Renal Software Suite customers. The letters described the software anomalies associated with the software and provided interim workaround instructions until permanent corrective actions to these anomalies can be identified. |
| Quantity | 4,148 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990953 | RENAL LINK Baxter Healthcare Corp, Jun 18, 1999 |