The Recall Desk
ModerateFDA (Devices)·Z-1938-2013·Announced 2013-08-21

Atrium Medical Recalls C-QUR V-Patch Mesh Due to Adhesion Issues

Atrium Medical Corporation is recalling C-QUR V-Patch Mesh units because the coated mesh may adhere to the inner packaging liner when exposed to high humidity.

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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a packaging/adhesion issue related to humidity, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Atrium Medical Corporation is recalling C-QUR V-Patch Mesh (all sizes and shapes), which is intended for use in soft tissue deficiencies. The recall involves 95,286 units with lot number 10405513 and higher. The product was distributed nationwide in the United States, including Puerto Rico, as well as in numerous international locations.

The recall was initiated because the coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions. This issue may affect the usability or integrity of the device during storage or handling.

Healthcare providers and facilities that have received this product should stop using it and contact Atrium Medical Corporation for further instructions on how to return or dispose of the affected units.

The recalled product

Product
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Affected units
95,286

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 →