BEUDAMED
    FDA Recall Terminated

    Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

    Recall: Z-1024-2013 · Initiated June 13, 2011

    Recall

    Recall Number
    Z-1024-2013
    Event Number
    64448
    Firm
    Zyno Medical LLC
    FEI Number
    3006575795
    Product Code
    OPP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 13, 2011
    Posted
    March 29, 2013
    Terminated
    July 25, 2016
    Address
    10 Tech Circle, Natick, MA, 01760

    Description

    Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.

    Reason

    Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

    Action

    Zyno Medical initiated recall 6/13/11 to accounts advising of a Preventative Maintenance (PM) Schedule and a software upgrade Odometer to monitor counts of accumulative fluid volume infused by the unit. On 3/1/13, firm issued correction notice to users that have not had the software implemented on their unit. Units will be serviced at their scheduled PM. The notice identified the product, problem, and actions to be taken by the customers.

    Distribution

    Nationwide Distribution.

    Quantity

    2589 units