Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1 recalled over foreign material

Recall date

September 12, 2018

Source

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

Official notice title

CMP Industries, Llc recalls Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elasti…

Recall number

Z-0293-2019

FDA classification

Class II

Brand / firm

CMP Industries, Llc

Sold / distributed

Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.

Why it was recalled

Foreign material in product

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

What was recalled

Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards