BEUDAMED
    FDA Recall Terminated

    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

    Recall: Z-0565-03 · Initiated December 23, 2002

    Recall

    Recall Number
    Z-0565-03
    Event Number
    25284
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2002
    Posted
    February 21, 2003
    Terminated
    December 11, 2007
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

    Reason

    Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy

    Action

    Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.

    Distribution

    Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.