Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
- 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.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- BALT USA, LLC
- Reason for Recall:
- Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Product Codes/Lot Numbers:
Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
Distribution:
Distributed in: AZ, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1680-2022
Related Recalls
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.