The Recall Desk
ModerateFDA (Devices)·Z-2097-2016·Announced 2016-07-06

CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust

CMP Industries is recalling 77 units of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected product is distributed in six US states and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is the possible presence of foreign material (rust), which is a low-risk contamination issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

CMP Industries, LLC is recalling 77 units of IMPAK Liquid Acrylic Resin. The product is sold under various labels, including IMPAK Elastic Acrylic Resin Liquid for Mouthguards & Bruxism Splints and Brux-Eze. The recall is due to the possible presence of foreign material, specifically rust.

The affected lot number is 79943, with an expiration date of March 2021. The product was distributed domestically in Michigan, Minnesota, New Jersey, New Mexico, New York, and Pennsylvania, as well as internationally in Canada.

Consumers who have this product should stop using it and contact CMP Industries, LLC for further instructions or a refund. The recall is classified as Class II by the FDA.

The recalled product

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), R
Manufacturer
CMP Industries, Llc
Category
Medical Device — Dental Materials
Hazard
Affected units
77

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 79943 Expiration Date: March 2021

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by CMP Industries, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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