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

Recall date

September 28, 2017

Source

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

Recall number

Z-0741-2018

FDA classification

Class II

Brand / firm

Cosmedent, Inc.

Sold / distributed

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

Why it was recalled

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

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

What was recalled

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