C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product lines with lot number 10405513 and higher
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Atrium Medical Corporation
- Reason for Recall:
- Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Product Codes/Lot Numbers:
Product lines with lot number 10405513 and higher
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1936-2013
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