Baxter Healthcare Renal Div Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
product code RENLSFT, all software versions
Products Sold
product code RENLSFT, all software versions
Baxter Healthcare Renal Div is recalling Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 due to There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026