BEUDAMED
    FDA Recall Terminated

    ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.

    Recall: Z-1817-2008 · Initiated May 12, 2008

    Recall

    Recall Number
    Z-1817-2008
    Event Number
    48115
    Firm
    Clinical Innovations, LLC
    FEI Number
    1000220650
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 12, 2008
    Posted
    September 2, 2008
    Terminated
    September 25, 2008
    Address
    747 W 4170 S, Salt Lake City, UT, 84123-1364

    Description

    ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.

    Reason

    Inadequate package seal could compromise sterility.

    Action

    Consignees were notified by letter on 05/12/2008 with instructions to conduct the recall to the end user. All remaining product is to be quarantined and returned to CI. A response form was included and a letter template to use in any sub-recall. Contact Richard Dixon at 801-268-8200 if you have questions.

    Distribution

    CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.

    Quantity

    260 units