Class 3 Device Recall UltraFiltration (UF) Removal Regulators

• Date Initiated by Firm: June 21, 2006
• Date Posted: July 25, 2006
• Recall Status: Terminated on March 04, 2008
• Recall Number: Z-1253-06
• Recall Event ID: 35706
• 510(K)Number: K030099 K103562 K910215 K970446
• Product Classification: UF Removal Regulators - Product Code KDI
• 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
• Code Information: item number 6001276024, lot numbers 01095126 and 01092479; part number 6001276028, lot number 01095127
• Recalling Firm/ Manufacturer: Baxter Healthcare Renal Div; 1620 Waukegan Rd Bldg R; Mc Gaw Park IL 60085-6730
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI; 510(K)s with Product Code = KDI; 510(K)s with Product Code = KDI; 510(K)s with Product Code = KDI