BEUDAMED
    FDA Recall Terminated

    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

    Recall: Z-2098-2015 · Initiated June 19, 2015

    Recall

    Recall Number
    Z-2098-2015
    Event Number
    71582
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HDX
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    June 19, 2015
    Posted
    July 17, 2015
    Terminated
    February 1, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

    Reason

    Incorrect expiration date on outer carton kit label

    Action

    CooperSurgical sent an Urgent Medicall Device Recall dated June 19, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt Form for a replacement. For questions call 203.601.5200.

    Distribution

    US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.

    Quantity

    40 kits