BEUDAMED
    FDA Enforcement Class II Terminated

    STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.

    Recall: Z-2161-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2161-2019
    Event ID
    83329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    July 1, 2019
    Classification Date
    August 6, 2019
    Termination Date
    June 26, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.

    Reason

    Potential for sterile packaging to be compromised

    Code Info

    Lot # 2019041790 Exp 3/31/2024 Lot # 2019030490 Exp 2/29/2024

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.

    Quantity

    From Lot # 2019041790, total distributed 2825 each and Lot # 2019030490, total distributed 3500 each