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

Recalled July 6, 2016 · FDA recall Z-2097-2016 · CMP Industries

Hazard

Possible presence of foreign material (rust). · FDA Class II

Units

77 units Total

Sold at

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

Description

Possible presence of foreign material (rust).

Product

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.

Manufacturer(s)

CMP Industries, Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →