Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot No. B7DS3
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Incorrect packaging of regular set and fast set cartridges.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Product Codes/Lot Numbers:

Lot No. B7DS3

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0812-2013

Related Recalls

Due to a manufacturing issue, red particulates present in the expressed composite.

Aug 2, 2024 Infusion Pumps Nationwide View Details →

Due to a manufacturing issue, red particulates present in the expressed composite.

Aug 2, 2024 Infusion Pumps Nationwide View Details →

Due to a manufacturing issue, red particulates present in the expressed composite.

Aug 2, 2024 Infusion Pumps Nationwide View Details →