BEUDAMED
    FDA Recall Terminated

    Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case

    Recall: Z-0340-04 · Initiated December 5, 2003

    Recall

    Recall Number
    Z-0340-04
    Event Number
    27896
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2003
    Posted
    July 20, 2004
    Terminated
    July 30, 2004
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case

    Reason

    Reports of loosening of the connections and disconnection of the device.

    Action

    Baxter sent recall letters dated 12/5/03 to the accounts in the United Kingdom and recall letters dated 12/8/03 to the accounts in Canada, informing them of the reports of loosening of the connections and disconnection of the device, and requesting that they discontinue use of product codes involved and revert the enrolled patients back to their traditional connection system.

    Distribution

    Canada and the United Kingdom

    Quantity

    10,030 units