BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    Recall: Z-1824-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1824-2015
    Event ID
    71313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 1, 2015
    Initiation Date
    April 13, 2015
    Classification Date
    June 22, 2015
    Termination Date
    February 5, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    Reason

    Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

    Code Info

    Work Order:164290

    Distribution

    Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.

    Quantity

    9400 units