BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1024-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1024-2013
    Event ID
    64448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zyno Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    June 13, 2011
    Classification Date
    March 29, 2013
    Termination Date
    July 25, 2016
    Address
    10 Tech Circle, N/A, Natick, MA, 01760, United States

    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

    Code Info

    LOT # 20080416-zs5, 20080711-zs5, 20080826-zs5, 20081022-zs5, 20090126-zs5 20090320-zs5, 20090507-zs5, 20090612-zs5, 20090706-zs5,20090910-zs5 20091110-zs5, 20100106-C, 20100420-D, 20100729, 20101005-BJ 20100910-SH, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH

    Distribution

    Nationwide Distribution.

    Quantity

    2589 units