Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
FDA Recall Z-0902-04 · Posted 2004-07-20
Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKPF
Date Initiated2004-04-12
Date Terminated2008-02-26
Product Quantity16 units
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.