BEUDAMED
    FDA Enforcement Class I Terminated

    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

    Recall: Z-2350-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2350-2012
    Event ID
    62132
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Medical Specialties, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    September 30, 2011
    Classification Date
    September 20, 2012
    Termination Date
    April 29, 2013
    Address
    330 East Main Street, Pine Level, NC, 27568, United States

    Description

    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

    Reason

    The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

    Code Info

    15011-0904 and 16363-0908

    Distribution

    US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.

    Quantity

    3 cases