Recall Z-0797-2019
Handpiece Headquarters · initiated April 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial #17C0001 to #17C0252
Reason for recall
Tip of the curing light was too hot causing a heat sensation in the patients.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0797-2019
- Initiated
- April 4, 2018
- Product code
- EBZ – Activator, Ultraviolet, For Polymerization
- 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 countries of Johannesburg, Panama, Suriname, and Trinidad.
- Recalling firm
- Handpiece Headquarters, Placentia, CA