FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
- Recall number
- Z-0901-04
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085
- Status
- Terminated
- Initiated
- 2004-04-12
- Posted
- 2004-07-20
- Terminated
- 2008-02-26
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 4,148 units
- Distribution
- Nationwide
- Lot, serial or model codes
- product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594, 5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534, 5M5597, 5M5541, 5M5541R, all software versions
- 510(k) numbers
- ["K990953"]
- PMA numbers
- not on file
- Product code
- KPF--
- Firm FEI
- 3000210122
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28