BEUDAMED
    FDA Recall Terminated

    Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

    Recall: Z-1416-2009 · Initiated April 2, 2009

    Recall

    Recall Number
    Z-1416-2009
    Event Number
    52008
    Firm
    Cook OB/Gyn, Inc.
    Product Code
    HFE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 2, 2009
    Posted
    June 16, 2009
    Terminated
    December 3, 2009
    Address
    1100 West Morgan St., Spencer, IN

    Description

    Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

    Reason

    There is an ink on the brush which has not been tested for use with the Tao Brush.

    Action

    The consignee was notified by an Urgent: Recall Notice letter dated 4/2/09. The customer is to forward the notice to all personnel that need to be aware of it; pull from their stock and isolate any affected product; and complete the form. Upon receipt of the form, Cook Women's Health will issue a Return Goods Authorization number and the customer should return the affected products via FedEx using the Return Goods Authorization number.

    Distribution

    Nationwide Distribution.

    Quantity

    15,396