Z-0833-03

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

Name: Z-0833-03 Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments...
Creator: Baxter Healthcare Corp.
Published: 2003-03-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-03-20 / Terminated

FDA source

Baxter Healthcare Corp. 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 2003-03-20. The reason FDA records is "The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0833-03
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-05-15
Terminated: 2004-01-23
Recalling firm: Baxter Healthcare Corporation
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: FKP System, Dialysate Delivery, Single Patient
Reason for recall: The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764

Product code FKP

K910215Class IIDrake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. / cleared 1991-04-09

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)