BEUDAMED
    FDA Recall Terminated

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    Recall: Z-0663-2008 · Initiated September 13, 2007

    Recall

    Recall Number
    Z-0663-2008
    Event Number
    45413
    Firm
    Fertility Technology Resources, Inc.
    FEI Number
    3003889409
    Product Code
    MQF
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 13, 2007
    Posted
    January 19, 2008
    Terminated
    February 6, 2008
    Address
    4343 Shallowford Rd, Ste D-4, Marietta, GA, 30062

    Description

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    Reason

    Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

    Action

    All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.

    Distribution

    Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.

    Quantity

    not reported