BEUDAMED
    FDA Enforcement Class II Ongoing

    Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

    Recall: Z-0797-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0797-2019
    Event ID
    81459
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Handpiece Headquarters
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2019
    Initiation Date
    April 4, 2018
    Classification Date
    February 4, 2019
    Address
    620 S Placentia Ave, Placentia, CA, 92870-6300, United States

    Description

    Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

    Reason

    Tip of the curing light was too hot causing a heat sensation in the patients.

    Code Info

    Serial #17C0001 to #17C0252

    Distribution

    Worldwide distribution including US nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and to Guam. There was also military/government distribution, and countries of Johannesburg, Panama, Suriname, and Trinidad.

    Quantity

    252 curing lights (rec'd by recalling firm; 142 were further dist)