FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.
- Recall number
- Z-0528-2008
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.
- Status
- Terminated
- Initiated
- 2007-11-14
- Posted
- 2008-01-26
- Terminated
- 2010-02-03
- Reason
- Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
- Root cause
- Software design
- Action
- Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4. A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.
- Quantity
- 9 units
- Distribution
- Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom
- Lot, serial or model codes
- Versions 3.0 and 3.1, all Serial Numbers
- 510(k) numbers
- ["K061515"]
- 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