Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2, all serial numbers within the range of 1001 through 22000
Products Sold
product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2; all serial numbers within the range of 1001 through 22000
Baxter Healthcare Renal Div is recalling System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratou due to The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026