FDA recall Z-0741-2018

Cosmedent, Inc. · Class II · device

Product

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

Reason for recall

Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

Distribution

Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

Key facts

Status
Terminated
Initiation date
2017-09-28
Report date
2018-03-07
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2018