BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 4, 2018

    Recall

    Recall Number
    Z-0797-2019
    Event Number
    81459
    Firm
    Handpiece Headquarters
    FEI Number
    3007007357
    Product Code
    EBZ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 4, 2018
    Address
    620 S Placentia Ave, Placentia, CA, 92870-6300

    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.

    Action

    The initial letter was issued via regular mail on 4/4/2018 by the parent company of the recalling firm. It explained the reason for recall and requested the consignee to immediately cease distribution or use of the product and to return it.

    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)