BEUDAMED
    FDA Recall Terminated

    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

    Recall: Z-1782-2014 · Initiated May 13, 2014

    Recall

    Recall Number
    Z-1782-2014
    Event Number
    68317
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 13, 2014
    Posted
    June 11, 2014
    Terminated
    May 28, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934

    Description

    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

    Reason

    Sterility of the device may be compromised due to unsealed pouch

    Action

    Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.

    Distribution

    Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.

    Quantity

    1180 units