BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1253-06 · Initiated June 21, 2006

    Recall

    Recall Number
    Z-1253-06
    Event Number
    35706
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2006
    Posted
    July 25, 2006
    Terminated
    March 4, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    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

    Reason

    The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.

    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.

    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.

    Quantity

    569 units