Z-0831-06

Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record...

Name: Z-0831-06 Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record...
Creator: Baxter Healthcare Renal Div
Published: 2006-03-29
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2006-03-29 / Terminated / root cause: software

FDA source

Baxter Healthcare Renal Div began a recall of Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter... on 2006-03-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0831-06
Status: Terminated
Initiated: 2006-03-29
Posted: 2006-05-03
Terminated: 2008-02-26
Recalling firm: Baxter Healthcare Renal Div
Product: 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
Product code: KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal
Reason for recall: 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 tag: software
FDA 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 their software version. At that time the mitigation provided in the letter will be reviewed with the customer.
Quantity in commerce: 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 Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
Product codes and lots: version 2.0 - HD Modules, PD Modules and Medical Record Modules only

Product code KPF

K990953Class IIRenal LinkBaxter Healthcare Corp / cleared 1999-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)