Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1936-2013·Announced 2013-08-21

Atrium Medical Recalls C-QUR Mesh Due to Packaging Adhesion Issues

Atrium Medical Corporation is recalling C-QUR Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the specific hazard is a packaging adhesion issue due to humidity rather than a direct structural defect or contamination, fitting the criteria for moderate severity involving minor labeling or packaging issues.

Plain-English summary

Atrium Medical Corporation is recalling C-QUR Mesh products, intended for use in soft tissue deficiencies. The recall involves 32,834 units of the mesh in all sizes and shapes. The specific issue identified is that the coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions.

The affected products are distributed nationwide in the USA, including Puerto Rico, as well as in numerous international locations including Australia, Canada, and various countries in Europe, Asia, and the Americas. The recall applies to product lines with lot number 10405513 and higher.

Healthcare providers and consumers should stop using the affected C-QUR Mesh products. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical Mesh
Hazard: packaging-defect
Affected units: 32,834

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)

Product lines with lot number 10405513 and higher

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Atrium Medical Corporation 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 4 products in this recall →

Same manufacturer · Atrium Medical Corporation

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