Atrium Medical Recalls C-QUR TacShield Mesh Due to Packaging Adhesion
Atrium Medical Corporation is recalling C-QUR TacShield Mesh units 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/storage issue (adhesion to liner) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Atrium Medical Corporation is recalling C-QUR TacShield Mesh (all sizes and shapes), a medical device intended for use in soft tissue deficiencies. The recall involves 15,630 units with lot number 10405513 and higher.
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 product during storage or handling.
The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in numerous international locations including Australia, Austria, Bahrain, Brazil, Canada, Chile, Colombia, the Dominican Republic, Ecuador, El Salvador, France, Germany, Great Britain, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Nicaragua, Norway, Panama, Peru, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and Venezuela. Healthcare providers and facilities should stop using the affected lots and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Mesh
- Affected units
- 15,630
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
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.
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