BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1782-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1782-2014
    Event ID
    68317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    May 13, 2014
    Classification Date
    June 11, 2014
    Termination Date
    May 28, 2015
    Address
    75 Vista Pl, N/A, Trumbull, CT, 06611-3934, United States

    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

    Code Info

    Lot 141525

    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