CMP Industries product recalled over foreign material

Recall date

April 28, 2016

Source

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

Official notice title

CMP Industries, Llc recalls IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRU…

Recall number

Z-2097-2016

FDA classification

Class II

Brand / firm

CMP Industries, Llc

Sold / distributed

Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

Why it was recalled

Possible presence of foreign material (rust).

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

What was recalled

IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.