Recall Z-0797-2019 ยท EBZ Activator, Ultraviolet, For Polymerization
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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.
| Date | Apr 4, 2018 |
| Status | Open, Classified |
| Reason | Tip of the curing light was too hot causing a heat sensation in the patients. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 252 curing lights (rec'd by recalling firm; 142 were further dist) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 Monitex Industrial Co., Ltd., Apr 21, 2006 |