FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
- Recall number
- Z-0833-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
- Status
- Terminated
- Initiated
- 2003-03-20
- Posted
- 2003-05-15
- Terminated
- 2004-01-23
- Reason
- The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
- Root cause
- Other
- Action
- Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change
- Quantity
- 25,014 units
- Distribution
- The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
- Lot, serial or model codes
- Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764
- 510(k) numbers
- ["K910215"]
- PMA numbers
- not on file
- Product code
- FKP
- Firm FEI
- 1416980
- Firm city
- Round Lake
- 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