Z-1253-06

Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s...

Name: Z-1253-06 Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s...
Creator: Baxter Healthcare Renal Div
Published: 2006-06-21
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2006-06-21 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Renal Div began a recall of Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora... on 2006-06-21. The reason FDA records is "The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1253-06
Status: Terminated
Initiated: 2006-06-21
Posted: 2006-07-25
Terminated: 2008-03-04
Recalling firm: Baxter Healthcare Renal Div
Product: Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare Corporation, Deerfield, IL 60015; item numbers 6001276024 and 6001276028
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 06/21/06 to all System 1000, TINA, Altratouch, Arena and Aurora Hemodialysis Instrument customers who may have received the nonconforming assemblies via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the three lots of UF Removal Regulators were potentially assembled incorrectly. While these regulators are identical in appearance to properly assembled components, the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy. Replacement regulators were included with the recall letter, and the accounts were requested to return the regulators from their previous shipment to Baxter using the enclosed mailing materials. The accounts were requested to complete the enclosed reply form indicating the number of units received and the number of units returned and acknowledging receipt of the letter and dissemination of the information to their staff and to other services of facilities, as applicable, and fax the sheet to 1-727-544-3025. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.
Quantity in commerce: 569 units
Distribution: Worldwide Distribution including the states of Arizona, California, Connecticut, Florida, Georgia, Maryland, Missouri, Ohio, Oklahoma, Tennessee, Texas and Puerto Rico, and international distribution to Belgium, Canada, Thailand, Chile, Austrailia, Peru, Argentina, Panama and Mexico.
Product codes and lots: item number 6001276024, lot numbers 01095126 and 01092479; part number 6001276028, lot number 01095127

Product code KDI

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)