BEUDAMED
    FDA Enforcement Class II Terminated

    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

    Recall: Z-1018-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1018-2013
    Event ID
    64510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    February 26, 2013
    Classification Date
    March 28, 2013
    Termination Date
    March 4, 2014
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

    Reason

    Incorrect size was printed on the outer product packaging.

    Code Info

    Lot 113367

    Distribution

    Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.

    Quantity

    80 individual diaphragms