Handpiece Headquarters recalls Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The lab

Recalled February 13, 2019 · FDA recall Z-0797-2019 · Handpiece Headquarters

Hazard

Tip of the curing light was too hot causing a heat sensation in the patients. · FDA Class II

Units

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

Sold at

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.

Description

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

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.

Manufacturer(s)

Handpiece Headquarters

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →