FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: 82210399
- 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:
- Ostial Corporation
- Reason for Recall:
- Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Product Codes/Lot Numbers:
Lot: 82210399
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2309-2021