BEUDAMED
    FDA Recall Terminated

    AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.

    Recall: Z-0414-2007 · Initiated October 19, 2006

    Recall

    Recall Number
    Z-0414-2007
    Event Number
    37162
    Firm
    Ascent Healthcare Solutions, Inc.
    FEI Number
    1000132435
    Product Code
    NLM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 19, 2006
    Posted
    February 8, 2007
    Terminated
    October 31, 2008
    Address
    5307 Great Oak Dr, Lakeland, FL, 33815

    Description

    AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.

    Reason

    The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.

    Action

    The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.

    Distribution

    Nationwide

    Quantity

    1566