Recall Z-0831-06 ยท KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Baxter Healthcare Renal Div
Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
| Date | May 3, 2006 (initiated Mar 29, 2006) |
| Status | Terminated |
| Reason | Software Error: There are software discrepancies 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 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those issues identified in the letter specific to the |
| Quantity | 12 - U.S, 104 - International |
| Distribution | Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990953 | RENAL LINK Baxter Healthcare Corp, Jun 18, 1999 |