Z-0766-06

System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch...

Name: Z-0766-06 System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch...
Creator: Baxter Healthcare Renal Div
Published: 2006-02-24
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2006-02-24 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A on 2006-02-24. The reason FDA records is "The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0766-06
Status: Terminated
Initiated: 2006-02-24
Posted: 2006-04-18
Terminated: 2008-10-28
Recalling firm: Baxter Healthcare Renal Div
Product: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Product code: FKP System, Dialysate Delivery, Single Patient
Reason for recall: The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 02/24/06 to all System 1000, TINA, Altratouch and Aurora Hemodialysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential for the older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators to become cracked due to mechanical and thermal stress. Color photographs of the old style and new style components were included in the letter. The accounts were informed that if the cracking occurs during patient treatment, the potential exists for an ultra filtration error to occur, which can result in excessive removal of fluid from the patient. Baxter provided a chart to determine which upgrade kit is required for each unit, based on the serial number involved. The accounts were requested to complete the enclosed Action Completion Response form, indicating the instrument serial number and which parts are needed for each machine at the site, and fax the sheet to 1-727-544-3025. Upon receipt of the Action Completion Reply form, a Baxter Field Service Engineer will call the account to schedule the upgrades. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.
Quantity in commerce: 14,917 units
Distribution: Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Lebanon, Morocco, the Netherlands, Nigeria, Oman, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, UAE, UK, Turkey, Colombia, Dominican Republic, Trinidad, Jamaica, St. Croix, Brazil, Peru, Ecuador, Australia, Argentina, Paraguay, Uruguay, China, Korea, Taiwan, Philippines, India, Singapore, Malaysia, Thailand, Indonesia and Canada.
Product codes and lots: product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2; all serial numbers within the range of 1001 through 22000

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)