BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1018-2013 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1018-2013
    Event Number
    64510
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    HDW
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 26, 2013
    Posted
    March 28, 2013
    Terminated
    March 4, 2014
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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.

    Action

    CSI notified consignees affected by this recall by a Recall Notification letter, dated February 26, 2013, sent via Federal Express with confirmed delivery receipt. The letter identified the affected product, and asked customers to contact the firm's Customer Service Department at 1-800-243-2974, if they had any of the affected lot in their inventory. Customers also have the option of completing the form attached to the letter and faxing it back to 800-262-0105. At CooperSurgical's expense, arrangements will made to replace the affected products that customers have on hand. The firm will provide further instruction and disposition of the product at the time of replacement.

    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