iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
- 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:
- Atrium Medical Corporation
- Reason for Recall:
- There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Product Codes/Lot Numbers:
UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0024-2025
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