BEUDAMED
    FDA Enforcement Class II Terminated

    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

    Recall: Z-2570-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2570-2014
    Event ID
    68754
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 3, 2014
    Classification Date
    September 5, 2014
    Termination Date
    May 28, 2015
    Address
    75 Vista Pl, N/A, Trumbull, CT, 06611-3934, United States

    Description

    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

    Reason

    Unsealed pouches.

    Code Info

    Lot 153914

    Distribution

    Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.

    Quantity

    1,400 units