BEUDAMED
    FDA Enforcement Class III Terminated

    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

    Recall: Z-0744-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0744-2013
    Event ID
    64135
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    January 17, 2013
    Classification Date
    February 4, 2013
    Termination Date
    May 18, 2016
    Address
    1669 Lake Avenue, N/A, Rochester, NY, 14652-3401, United States

    Description

    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

    Reason

    Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a

    Code Info

    Lot 2114596 (Exp. September 2014)

    Distribution

    US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

    Quantity

    101 cartons: Domestic - 95 cartons; Foreign - 6 cartons