Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085

FDA Recall Z-0901-04 · Posted 2004-07-20

Recalling FirmBaxter Healthcare Renal Div
Recall StatusTerminated
Product CodeKPF
Date Initiated2004-04-12
Date Terminated2008-02-26
Product Quantity4,148 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.

K990953RENAL LINKBaxter Healthcare Corp · 1999-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑