BEUDAMED
    FDA Recall Terminated

    Latex Dental Dams labeled as Non-Latex Dental Dams

    Recall: Z-2151-2014 · Initiated December 11, 2013

    Recall

    Recall Number
    Z-2151-2014
    Event Number
    67640
    Firm
    Coltene Whaledent Inc
    FEI Number
    2416455
    Product Code
    EIE
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    December 11, 2013
    Posted
    August 6, 2014
    Terminated
    August 26, 2016
    Address
    235 Ascot Parkway, Cuyahoga Falls, OH, 44223

    Description

    Latex Dental Dams labeled as Non-Latex Dental Dams

    Reason

    Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

    Action

    The firm issued a press release, called the distributor and sent a certified letter. The firm obtained the distributor's distribution list and sent recall notifications to all of these consignees.The firm included envelopes and return/reply cards, via response form mailed, certified mailing with return receipt.

    Distribution

    Distributed in Memphis, TN.

    Quantity

    32 boxes, 15 individual dams per box