FDA recall Z-0797-2019

Handpiece Headquarters · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2018-04-04
Report date
2019-02-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Placentia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2019