Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
FDA device recall Z-0901-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPF
- Quantity affected
- 4,148 units
- Distribution
- Nationwide
- Date initiated
- 2004-04-12
- Date posted
- 2004-07-20
- Date terminated
- 2008-02-26
- Location
- Park, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENAL LINK (K990953) | Baxter Healthcare Corp | 1999-06-18 |