BEUDAMED
    FDA Enforcement Class II Terminated

    Latex Dental Dams labeled as Non-Latex Dental Dams

    Recall: Z-2151-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2151-2014
    Event ID
    67640
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 13, 2014
    Initiation Date
    December 11, 2013
    Classification Date
    August 6, 2014
    Termination Date
    August 26, 2016
    Address
    235 Ascot Parkway, N/A, Cuyahoga Falls, OH, 44223, United States

    Description

    Latex Dental Dams labeled as Non-Latex Dental Dams

    Reason

    Colt¿ne/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.

    Code Info

    Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

    Distribution

    Distributed in Memphis, TN.

    Quantity

    32 boxes, 15 individual dams per box