Home / Recalls / Handpiece Headquarters / Z-0797-2019

Z-0797-2019 Class II Ongoing

Recalled by Handpiece Headquarters — Placentia, CA

Recall Details

Product Type: Devices
Report Date: February 13, 2019
Initiation Date: April 4, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 252 curing lights (rec'd by recalling firm; 142 were further dist)

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Serial #17C0001 to #17C0252