BEUDAMED
    FDA Enforcement Class I Terminated

    0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

    Recall: Z-0007-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0007-2017
    Event ID
    75031
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Corporation Englewood
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    August 24, 2016
    Classification Date
    October 6, 2016
    Termination Date
    July 26, 2017
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

    Reason

    Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.

    Code Info

    All unexpired lots-Product Code: H93835

    Distribution

    Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    202,647