Baxter Healthcare Renal Div 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
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 Renal Div
Lot Codes / Batch Numbers
Serial numbers 1001S to 1142S, 50001 to 52109, 01001 to 26231
Products Sold
Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231
Baxter Healthcare Renal Div is recalling Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instr due to These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
Recommended Action
Per FDA guidance
Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dialysis treatments are complete at the end of the day. The machine is had-powered off by placing the main power switch located in the back of the machine into the OFF position. If the facility typically performs a heat clean cycle of machines after treatments are completed, it is imperative that the machines are hard powered off at the completion of the cycle. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 1, Monday through Friday, 8:30 AM to 6:00 PM EST.
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