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

Recall date

April 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0797-2019

FDA classification

Class II

Brand / firm

Handpiece Headquarters

Sold / distributed

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 c…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.