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U.S. Department of Health and Human Services

Class 2 Device Recall CU1000 Halogen Curing Light

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 Class 2 Device Recall CU1000 Halogen Curing Lightsee related information
Date Initiated by FirmApril 04, 2018
Create DateFebruary 04, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0797-2019
Recall Event ID 81459
510(K)NumberK060646 
Product Classification Activator, ultraviolet, for polymerization - Product Code EBZ
ProductHenry 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.
Code Information Serial #17C0001 to #17C0252
FEI Number 3007007357
Recalling Firm/
Manufacturer		 Handpiece Headquarters
620 S Placentia Ave
Placentia CA 92870-6300
For Additional Information ContactMr. Timothy Ropchan
717-335-7230
Manufacturer Reason
for Recall		Tip of the curing light was too hot causing a heat sensation in the patients.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce252 curing lights (rec'd by recalling firm; 142 were further dist)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EBZ
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