BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    Recall: Z-0194-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0194-2016
    Event ID
    72362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    October 6, 2015
    Classification Date
    October 30, 2015
    Termination Date
    June 27, 2016
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    Reason

    Leakage from the inlet port of the 15L Cycler Drainage Bags.

    Code Info

    H15C11095

    Distribution

    US Distribution and Internationally to Canada.

    Quantity

    19,440 units