Z-0395-05

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

Name: Z-0395-05 Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments...
Creator: Baxter Healthcare Renal Div
Published: 2003-05-28
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2003-05-28 / 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 2003-05-28. The reason FDA records is "The air detector may not detect air bubbles consistently at the selected limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0395-05
Status: Terminated
Initiated: 2003-05-28
Posted: 2004-12-02
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: FKP System, Dialysate Delivery, Single Patient
Reason for recall: The air detector may not detect air bubbles consistently at the selected limit.
FDA root cause: Other
Action: Important Product Information letters were sent to customers on 5/28/03, informing them of the potential for the air detector not detecting air bubbles consistently. The letters instructed the accounts to measure the air detector sensor voltage output on each of their instruments, using the enclosed instructions, to determine whether the installation of an air detector attenuator connector is needed. The instructions also included directions for installation of the attenuator connector. Since the instrument requires re-qualification after the testing and installation, the accounts were given the choice to have the testing and installation done during the next service call or as part of the instrument''s next normally scheduled maintenance.
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, the Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Malaysia, Morocco, the Netherlands, Oman, Palestine, Panama, Peru, the Philippines, Poland, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
Product codes and lots: All System 1000 units with serial numbers prior to 22224.

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)