BEUDAMED
    FDA Recall Terminated

    Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.

    Recall: Z-0695-2007 · Initiated January 4, 2007

    Recall

    Recall Number
    Z-0695-2007
    Event Number
    37306
    Firm
    Gambro Renal Products, Inc.
    FEI Number
    1713683
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 4, 2007
    Posted
    March 31, 2007
    Terminated
    January 3, 2012
    Address
    10810 W Collins Ave, Lakewood, CO, 80215-4439

    Description

    Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.

    Reason

    Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)

    Action

    Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.

    Distribution

    Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.

    Quantity

    153 units (Domestic)