BEUDAMED
    FDA Recall Terminated

    Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.

    Recall: Z-1576-2009 · Initiated July 23, 2008

    Recall

    Recall Number
    Z-1576-2009
    Event Number
    52170
    Firm
    Inovel LLC
    FEI Number
    1000098753
    Product Code
    MSH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 23, 2008
    Posted
    July 13, 2009
    Terminated
    July 17, 2009
    Address
    10111 Jefferson Blvd, Culver City, CA, 90232-3509

    Description

    Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.

    Reason

    Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.

    Action

    The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835.

    Distribution

    US (Illinois only).

    Quantity

    80 cases