Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
This recall has been terminated (originally issued July 20, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- April 12, 2004
- Posted
- July 20, 2004
- Terminated
- February 26, 2008
- Recall Number
- Z-0901-04
- Quantity
- 4,148 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594, 5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534, 5M5597, 5M5541, 5M5541R, all software versions
Root Cause
Other
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.