Baxter Healthcare Corp. Rt 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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Baxter Healthcare Corp. Rt
Lot Codes / Batch Numbers
Serial numbers 1001S to 1142S, 50001 to 52109, 01001 to 23764
Products Sold
Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764
Baxter Healthcare Corp. Rt is recalling Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instr due to The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026