Z-1394-05

Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T...

Name: Z-1394-05 Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T...
Creator: Baxter Healthcare Renal Div
Published: 2005-06-14
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2005-06-14 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare... on 2005-06-14. The reason FDA records is "Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1394-05
Status: Terminated
Initiated: 2005-06-14
Posted: 2005-08-24
Terminated: 2008-02-26
Recalling firm: Baxter Healthcare Renal Div
Product: Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
Product code: JPI Device, Hematocrit Measuring
Reason for recall: Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.
FDA root cause: Other
Action: Baxter sent Important Product Information letters dated 6/14/05 to all System 1000 and Arena Hemodialysis customers, to the attention of the Hemodialysis Administrator, via first class mail. Enclosed with the letter were copies of addenda to the Operator''s Manual for both the System 1000 and Arena instruments. The letter informed the accounts of the following problems: a) Improper Syringe Size - it is important to use the correct syringe size for heparin infusion to avoid improper infusion of heparin. The warning 'Ensure the instrument is properly configured for the type and size of heparin pump syringe being installed.' was added to the manual under the Priming the Dialyzer and Blood Lines section of Operation. b) Disinfection Infusion Monitor (System 1000 only) - Procedural steps have been added to the System 1000 manual to confirm the level in the disinfectant bottle prior to and after chemical disinfection to ensure that disinfection fluid has been utilized during the disinfection cycle. c) TMP Advise - the 'TMP Alarm in Dialyzer Mode' section in both the System 1000 and Arena manuals has been removed. d) Bicarbonate Value - the Dialysate Preparation section of the manual was revised to clarify the bicarbonate display of the System 1000 and Arena instruments. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898.
Quantity in commerce: 14,917 units
Distribution: Nationwide and internationally to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, India, Indonesia, Korea, Mexico, Peru, Philippines, Singapore, Spain, Switzerland, Taiwan, Thailand and Turkey.
Product codes and lots: all serial numbers

Product code JPI

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

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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)