PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
- 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:
- Ultradent Products, Inc.
- Reason for Recall:
- Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Product Codes/Lot Numbers:
Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0053-2021
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