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.

Company

Handpiece Headquarters

Recall Initiated

April 4, 2018

Recall Number

Z-0797-2019

Quantity

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

Firm Location

Placentia, CA

Reason for Recall

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

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.

Lot / Code Info

Serial #17C0001 to #17C0252

Root 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.