BEUDAMED
    FDA Enforcement Class II Terminated

    Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

    Recall: Z-1878-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1878-2016
    Event ID
    74004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 8, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    June 1, 2016
    Termination Date
    December 16, 2016
    Address
    5900 1st Ave S, N/A, Seattle, WA, 98108-3248, United States

    Description

    Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

    Reason

    The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.

    Code Info

    Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.

    Distribution

    distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.

    Quantity

    21 filters