BEUDAMED
    FDA Recall Terminated

    Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401

    Recall: Z-1367-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-1367-2008
    Event Number
    45950
    Firm
    Gambro Renal Products, Inc.
    FEI Number
    1713683
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 10, 2007
    Posted
    March 25, 2008
    Terminated
    January 3, 2012
    Address
    14143 Denver West Pkwy, Lakewood, CO, 80401-3116

    Description

    Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401

    Reason

    Kinked tubing on hemodialysis device may cause hemolysis.

    Action

    On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.

    Distribution

    Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.

    Quantity

    41,000,000