BEUDAMED
    FDA Recall 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 · Initiated January 17, 2013

    Recall

    Recall Number
    Z-0744-2013
    Event Number
    64135
    Firm
    Carestream Health, Inc.
    FEI Number
    1317267
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    January 17, 2013
    Posted
    January 28, 2013
    Terminated
    May 18, 2016
    Address
    1669 Lake Avenue, Rochester, NY, 14652-3401

    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

    Action

    Carestream sent an Urgent Customer Notification and Field Corrective Action Letters dated January 17, 2013 and response form to the domestic consignees via UPS Overnight Mail. The letter identified the affected product, problem and actions to be taken. In addition, the consignees were instructed to complete the response form and fax it back to Carestream to fax # 585-323-7643. For questions or concerns customers were instructed to contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.

    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