Z-0583-04

Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments...

Name: Z-0583-04 Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments...
Creator: Baxter Healthcare Renal Div
Published: 2004-02-20
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2004-02-20 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina... on 2004-02-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0583-04
Status: Terminated
Initiated: 2004-02-20
Posted: 2004-07-20
Terminated: 2008-02-26
Recalling firm: Baxter Healthcare Renal Div
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
Product code: FII System, Dialysate Delivery, Sealed
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 28,482 units
Distribution: The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Lebanon, Morocco, Malaysia, the Netherlands, Oman, Panama, Preu, Philippines, Poland, Palestine, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and United Kingdom.
Product codes and lots: Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231

Product code FII

K970446Class IIDrake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl / cleared 1997-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)